510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD September 2016 TOTAL 510(k)s THIS PERIOD 257 TOTAL WITH SUMMARIES 250 TOTAL WITH STATEMENTS 7 DEVICE: BBX1, BBX2, BBX1MO, BBX1MC GLOBALDENTAL, INC. 510(k) NO: K142846(Traditional) ATTN: EBLESS V BAEZ ALERS PHONE NO : 787 8440345 SAN ANTONIO DRAMA ST. 2067 SE DECISION MADE: 08-SEP-16 PONCE PR 00728 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CPL Insulin Pen Needle CPL CO., LTD. 510(k) NO: K151090(Traditional) ATTN: CHOI KYOUNG SOO PHONE NO : 82 31 4837301 36, YONGTEURIM-GIL, DANWON-GU SE DECISION MADE: 21-SEP-16 ANSAN KP 425-430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VSP Cranial System 3D Systems, Inc. 510(k) NO: K151285(Traditional) ATTN: Kim Torluemke PHONE NO : 303 2735344 17301 West Colfax Avenue, Suite 30SE DECISION MADE: 23-SEP-16 Golden CO 80401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3Shape Abutment Designer Software 3Shape A/S 510(k) NO: K151455(Traditional) ATTN: Hanne Nielsen PHONE NO : 45 702 72620 Holemens Kanal 7 SE DECISION MADE: 06-SEP-16 Copenhagen DK 1060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD MAX CT/GC/TV, BD MAX INSTRUMENT BECTON, DICKINSON, AND COMPANY 510(k) NO: K151589(Traditional) ATTN: KATIE COYLE PHONE NO : 410 3164975 7 LOVETON CIR. MC:694 SE DECISION MADE: 06-SEP-16 SPARKS MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMC Health VitalCaregiving System AMC Health 510(k) NO: K151839(Traditional) ATTN: Jonathan Shankman PHONE NO : 212 5370827 39 Broadway, Suite 540 SE DECISION MADE: 09-SEP-16 New York NY 10006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KBL Sunlamp Products (= Device Bundling name) KBL AG 510(k) NO: K151962(Traditional) ATTN: NORBERT BECKER PHONE NO : 49 02689 9426525 RINGSTRASSE 24-26 SE DECISION MADE: 15-SEP-16 DERNBACH DE 56307 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Xprecia Stride Coagulation System, Xprecia System PT Controls SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K151964(Traditional) ATTN: NOOR MALKI PHONE NO : 781 2693401 2 EDGEWATER DRIVE SE DECISION MADE: 30-SEP-16 NORWOOD MA 02062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Luminesse Shaded Zirconia SZ TALLADIUM, INC. 510(k) NO: K152023(Traditional) ATTN: Edward Harms PHONE NO : 661 2950900 27360 WEST MUIRFIELD LANE SE DECISION MADE: 15-SEP-16 VALENCIA CA 91355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RENASYS GO SMITH & NEPHEW, INC. 510(k) NO: K152163(Traditional) ATTN: Laura Reynolds PHONE NO : 727 3297702 970 LAKE CARILLON DRIVE SUITE 110 SE DECISION MADE: 29-SEP-16 ST. PETERSBURG FL 33716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IBL 5000 Tanning Booth IBL ACQUISITIONS LLC 510(k) NO: K152405(Traditional) ATTN: MICHAEL GILLEY PHONE NO : 317 2171700 2653 TOBEY DRIVE SE DECISION MADE: 01-SEP-16 INDIANAPOLIS IN 46219 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRACOE smart Cuff Manager TRACOE MEDICAL GMBH 510(k) NO: K152865(Traditional) ATTN: STEPHAN KOHLER PHONE NO : 49 0 61369169 0 REICHELSHEIMER STR. 1/3 SE DECISION MADE: 27-SEP-16 NIEDER-OLM DE D-55268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sure-Fine Insulin Syringes SHINA MED CORPORATION 510(k) NO: K152879(Traditional) ATTN: SUNG-SOON PARK PHONE NO : 82 31 80572125 455-30, BOGAWONSAM-RO BOGAE-MYUN SE DECISION MADE: 09-SEP-16 ANSEONG-SI KR 456-871 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEMPEDY SEIRATHERM GMBH 510(k) NO: K152946(Traditional) ATTN: MATTHIAS ROTH PHONE NO : 49 898 09131420 BEETHOVEN STREET. 10 SE DECISION MADE: 15-SEP-16 91074 HERZOGENAURACH DE 13033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JET SET 4 DENTURE REPAIR RESIN LANG DENTAL MANUFACTURING COMPANY,510(k) NO: K152981(Traditional) ATTN: DAVID LANG PHONE NO : 800 2225264 175 MESSNER DRIVE SE DECISION MADE: 02-SEP-16 WHEELING IL 60090 510(k) STATEMENT DEVICE: HAMILTON-MR1 HAMILTON MEDICAL AG 510(k) NO: K153046(Traditional) ATTN: KATRIN VOGT PHONE NO : 41 58 6101479 VIA CRUSCH 8 SE DECISION MADE: 06-SEP-16 BONADUZ, GRISONS CH 7402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Initial LiSi Block GC AMERICA INC. 510(k) NO: K153130(Traditional) ATTN: MARK HEISS PHONE NO : 708 5970900 3737 W. 127TH STREET SE DECISION MADE: 13-SEP-16 ALSIP IL 60803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: eCareManager 4.0.1 VISICU, INC. 510(k) NO: K153156(Traditional) ATTN: Daniel R. Plonski PHONE NO : 410 2465357 217 E. REDWOOD ST., STE. 1900 SE DECISION MADE: 30-SEP-16 BALTIMORE MD 21202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Additive Orthopaedics Bone Wedge System Additive Orthopaedics, LLC 510(k) NO: K153207(Traditional) ATTN: GREGORY KOWALCZYK PHONE NO : 732 8826633 83 Amelia Circle SE DECISION MADE: 07-SEP-16 Little Silver NJ 07739 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: coflex-IF PARADIGM SPINE, LLC 510(k) NO: K153302(Traditional) ATTN: Marc Viscogliosi PHONE NO : 212 5839700 103 505 PARK AVENUE, 14TH FLOOR SE DECISION MADE: 08-SEP-16 NEW YORK NY 10022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Flexitouch System TACTILE SYSTEMS TECHNOLOGY INC (DB510(k) NO: K153311(Traditional) ATTN: Thomas A Dold PHONE NO : 612 3555100 1331 Tyler St NE, Ste 200 SE DECISION MADE: 14-SEP-16 MINNEAPOLIS MN 55413 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Luna CPAP and Auto CPAP System 3B MEDICAL, INC. 510(k) NO: K153387(Traditional) ATTN: ALEX LUCIO PHONE NO : 1 863 2266285 21301 HWY 27 SE DECISION MADE: 08-SEP-16 LAKE WALES FL 33859 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cathtong I PICC Catheter L&Z US, INC. 510(k) NO: K153469(Traditional) ATTN: JENELLA COUTTS PHONE NO : 718 6010889 1 6 HORIZON ROAD, #2301 SE DECISION MADE: 01-SEP-16 FORT LEE NJ 07024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: F&P Eson 2 Nasal Mask FISHER & PAYKEL HEALTHCARE LIMITED510(k) NO: K153505(Traditional) ATTN: SUE CHO PHONE NO : 64 957 40100 15 MAURICE PAYKEL PLACE EAST TAMAKSE DECISION MADE: 20-SEP-16 Auckland NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pelican Sling Retractor Beacon Surgical, Inc. 510(k) NO: K153542(Traditional) ATTN: Allan Alward PHONE NO : 914 4795108 145 Palisade Street SE DECISION MADE: 07-SEP-16 Dobbs Ferry NY 10522 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PINK CAD/CAM disc POLIDENT D.O.O., DENTAL PRODUCTS I510(k) NO: K153546(Traditional) ATTN: JANJA LIPUSCEK PHONE NO : 00386 53304859 VOLCJA DRAGA 42 SE DECISION MADE: 28-SEP-16 VOLCJA DRAGA SI 5293 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DONASORB SILVER WOUND DRESSING VIRCHOW BIOTECH PVT. LTD. 510(k) NO: K153565(Traditional) ATTN: BRUCE GIBBINS PHONE NO : 971 503781 7565 5903, SE MILWAUKIE AVENUE SE DECISION MADE: 22-SEP-16 PORTLAND OR 97202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Central Monitoring System GUANGDONG BIOLIGHT MEDITECH CO., L510(k) NO: K153580(Traditional) ATTN: Jin Liang PHONE NO : 86 756 3399967 NO. 2 INNOVATION FIRST ROAD TECHNSE DECISION MADE: 07-SEP-16 ZHUHAI CN 519085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Concert Medical Hands-Free Syringe (HFS) Concert Medical, LLC 510(k) NO: K153599(Traditional) ATTN: Timothy S Powers PHONE NO : 781 2617407 77 Accord Park Drive SE DECISION MADE: 01-SEP-16 Norwell MA 02061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RTS Flexible 1 MPJ Implant w/Grommets In2BonesUSA, LLC 510(k) NO: K153609(Traditional) ATTN: Joe Clift PHONE NO : 901 2607931 6060 Poplar Ave, Suite 380 SE DECISION MADE: 08-SEP-16 Mephis TN 38119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Liberator Powered Wheelchair with Solar Companion SOLAR MOBILITYLLC 510(k) NO: K153636(Traditional) ATTN: KURT SCHNEIDER PHONE NO : 509 8513611 1426 EAST 3RD AVENUE SE DECISION MADE: 09-SEP-16 KENNEWICK WA 99336 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II ELITechGroup 510(k) NO: K153644(Traditional) ATTN: Valerie Gourdon PHONE NO : 330 233 812100 ZONE INDUSTRIELLE SE DECISION MADE: 07-SEP-16 Sees FR 61500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sentry WEB SmartInterp CareFusion Germany 234 GmbH 510(k) NO: K153654(Traditional) ATTN: Elmar Niedermeyer PHONE NO : 49 931 4972361 Leibnizstrasse 7 SE DECISION MADE: 16-SEP-16 Hoechberg DE 97204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: StealthStation System with Cranial Software MEDTRONIC NAVIGATION, INC. 510(k) NO: K153660(Traditional) ATTN: Augusta Henao PHONE NO : 720 8903366 826 COAL CREEK CIRCLE SE DECISION MADE: 14-SEP-16 LOUSVILLE CO 80027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROW FUSION-L NLT SPINE LTD 510(k) NO: K153665(Traditional) ATTN: Eti Zinger PHONE NO : 972 3 6344514 6 YAD HARUTZIM ST. SE DECISION MADE: 15-SEP-16 KFAR-SABA IL 4464103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEON III GENOSS CO., LTD. 510(k) NO: K153676(Traditional) ATTN: EUNSANG LEE PHONE NO : 82 70 70987568 1F GYEONGGI R&DB CENTER, 105 GWANGSE DECISION MADE: 14-SEP-16 SUWON-SI KR 433-270 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULYSS Multi View Sinuscope SOPRO-COMEG GMBH 510(k) NO: K153701(Traditional) ATTN: HAROLD LETTAU PHONE NO : 011 49 7461934429 DORNIERSTRASSE 55 SE DECISION MADE: 09-SEP-16 TUTTLINGEN DE 78532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROcedure Rehearsal Studio 3DSYSTEMS, SIMBIONIX PRODUCTS 510(k) NO: K153705(Special) ATTN: KIM TORLUEMKE PHONE NO : 972 391 14444 BEIT GOLAN CORNER OF GOLAN AND HANSE DECISION MADE: 02-SEP-16 AIRPORT CITY IL 70151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nihon Kohden Vital Sign Telemeter NIHON KOHDEN CORPORATION 510(k) NO: K153707(Traditional) ATTN: TOM BENTO PHONE NO : 949 6809048 1-31-4 NISHIOCHIAI, SHINJUKU-KU SE DECISION MADE: 02-SEP-16 TOKYO JP 161-8560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTICOAT Surgical Dressing Smith & Nephew Medical Limited 510(k) NO: K153723(Traditional) ATTN: Samantha Neilson PHONE NO : 44 1482 673790 101 Hessle Road SE DECISION MADE: 14-SEP-16 Hull GB HU3 2BN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VORTRAN Manometer VORTRAN MEDICAL TECHNOLOGY 1, INC.510(k) NO: K153733(Traditional) ATTN: JAMES LEE PHONE NO : 916 6488460 15 21 GOLDENLAND COURT, #100 SE DECISION MADE: 16-SEP-16 SACRAMENTO CA 95834 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Emergency Transtracheal Airway Catheter COOK INCORPORATED 510(k) NO: K153761(Traditional) ATTN: KOTEI AOKI PHONE NO : 812 3353575 102630 750 DANIELS WAY SE DECISION MADE: 22-SEP-16 BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TXM Guiding Sheath Texas Medical Technologies, Inc. 510(k) NO: K153771(Traditional) ATTN: Aaron Chiu PHONE NO : 915 7744321 9005 Montana Ave., Suite A SE DECISION MADE: 13-SEP-16 El Paso TX 79925 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pure Vu Motus GI Medical Technologies Ltd.510(k) NO: K160015(Traditional) ATTN: Hagit Ephrath PHONE NO : 972 52 3142045 22 Keren Ha'yesod St. SE DECISION MADE: 22-SEP-16 Tirat Carmel IL 3902638 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Electronic Stethoscope DS301 IMEDIPLUS INC. 510(k) NO: K160023(Traditional) ATTN: SHIRLEY LAI PHONE NO : 886 3 6587700 2F, 12, SHENGYI RD.SEC.2 SE DECISION MADE: 30-SEP-16 CHUBEI CITY TW 30261 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pro-Link® Stand-Alone Cervical Spacer System Life Spine, Inc. 510(k) NO: K160066(Traditional) ATTN: Randy Lewis PHONE NO : 847 8846117 13951 S. Quality Drive SE DECISION MADE: 02-SEP-16 Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AbClose - Port Site Closure Device Medeon Biodesign, Inc 510(k) NO: K160117(Traditional) ATTN: GRETA CHANG PHONE NO : 886 2 28816686 306 7F, 116, HouGang St SE DECISION MADE: 09-SEP-16 Taipei TW 11170 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Flowable Wound Matrix COOK BIOTECH INCORPORATED 510(k) NO: K160136(Traditional) ATTN: PERRY W. GUINN PHONE NO : 765 4973355 1425 INNOVATION PLACE SE DECISION MADE: 28-SEP-16 WEST LAFAYETTE IN 47906 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTRIa series HDX WILL CORP. 510(k) NO: K160140(Traditional) ATTN: Hyung-suk Oh PHONE NO : 82 437 107318 #105, 201, 202, 203, 204, 38 OSONGSE DECISION MADE: 30-SEP-16 Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Active-X Total Knee System Signature Orthopaedics Pty Ltd. 510(k) NO: K160159(Traditional) ATTN: Declan Brazil PHONE NO : 61 2 94285181 7 Sirius Road SE DECISION MADE: 06-SEP-16 Lane Cove AU 2066 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DePuy Synthes TFNA Augmentation System Synthes (USA) Products, LLC 510(k) NO: K160167(Traditional) ATTN: Christopher J. Medberry PHONE NO : 610 7196806 1301 Goshen Parkway SE DECISION MADE: 26-SEP-16 West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLANTIS ISUS Implant Suprastructures DENTSPLY INTERNATIONAL, INC. 510(k) NO: K160207(Traditional) ATTN: HELEN LEWIS PHONE NO : 717 4871332 221 WEST PHILADELPHIA ST. SUITE 60SE DECISION MADE: 21-SEP-16 YORK PA 17401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Implance Dental Implant System, Implance Dental Abutment System AGS Medikal Urunleri Ith. Ihr. Tic510(k) NO: K160221(Traditional) ATTN: Gorkem Serce PHONE NO : 0090 216 5460078 Mahmut Yesari Caddesi No: 25 SE DECISION MADE: 12-SEP-16 Istanbul TR 34718 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HBOTC Muscle and Nerve Stimulator HB MEDICAL, INC. 510(k) NO: K160255(Traditional) ATTN: RYAN HEANEY PHONE NO : 714 8430463 5702 BOLSA AVENUE SE DECISION MADE: 15-SEP-16 HUNTINGTON BEACH CA 92649 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, Institut Straumann AG 510(k) NO: K160262(Traditional) ATTN: Christopher Klaczyk PHONE NO : 41 61 9651260 Peter Merian Weg 12 SE DECISION MADE: 16-SEP-16 Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Surgical Face Masks (Ear loops and Tie-on) SAN-M PACKAGE CO., LTD. 510(k) NO: K160269(Abbreviated) ATTN: Shogo Nagao PHONE NO : 011 81 547454125 1086-1 Ojiro SE DECISION MADE: 06-SEP-16 Shimada-City JP 428-8652 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Hi bebe plus BISTOS CO., LTD. 510(k) NO: K160274(Traditional) ATTN: Jenny Cho PHONE NO : 82 31 7500340 7th Fl., A Bldg., Woolim Lions ValSE DECISION MADE: 01-SEP-16 Seongnam KR 13201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Colposcope System XUZHOU KERNEL MEDICAL EQUIPMENT CO510(k) NO: K160341(Traditional) ATTN: JING WANG PHONE NO : 86 516 87732208 KERNEL MANSION, ECONOMIC DEVELOPMESE DECISION MADE: 14-SEP-16 XUZHOU CN 221004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System Infopia Co., Ltd. 510(k) NO: K160365(Special) ATTN: NA YUN KIM PHONE NO : 82 31 4600415 132, Anyangcheondong-ro, Dongan-guSE DECISION MADE: 28-SEP-16 Anyang KR 14040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head Dental Savings Club 510(k) NO: K160410(Traditional) ATTN: Chadi Saade PHONE NO : 514 7686879 31 Serge Garant SE DECISION MADE: 29-SEP-16 Montreal CA h3E 0A6 510(k) STATEMENT DEVICE: Sterling 5W Diode Laser CAO Group, Inc. 510(k) NO: K160413(Traditional) ATTN: Robert K Larsen PHONE NO : 801 2569282 4628 West Skyhawk Drive SE DECISION MADE: 21-SEP-16 West Jordan UT 84084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Perineologic Access Needle Corbin Clinical Resources, LLC 510(k) NO: K160423(Traditional) ATTN: Kenneth K. Kleinhenz PHONE NO : 858 4580994 12234 Williams Road SE DECISION MADE: 02-SEP-16 Cumberland MD 21502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BC-5390 Auto Hematology Analyzer MINDRAY BIO-MEDICAL ELECTRONICS CO510(k) NO: K160429(Traditional) ATTN: Min Zheng PHONE NO : MINDRAY BUILDING, KEJI 12TH RD SOUSE DECISION MADE: 01-SEP-16 NANSHAN CN 518057 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CreoDent Solidex Custom Abutment CreoDent Prosthetics, Ltd. 510(k) NO: K160436(Traditional) ATTN: Calvin Shim PHONE NO : 212 3023860 29 West 30th Street, 11th Floor SE DECISION MADE: 29-SEP-16 New York NY 10001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TempoCem Clear DMG USA, INC. 510(k) NO: K160443(Traditional) ATTN: Gordon Craig PHONE NO : 508 2265660 23 FRANK MOSSBERG DRIVE SE DECISION MADE: 30-SEP-16 ATTLEBORO MA 02703 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm Salvin Dental Specialties 510(k) NO: K160493(Traditional) ATTN: Jennifer Singer PHONE NO : 704 4425400 3450 Latrobe Drive SE DECISION MADE: 08-SEP-16 Charlotte NC 28211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pledgeted COR-SUTURE QUICK LOAD LSI SOULTIONS 510(k) NO: K160529(Abbreviated) ATTN: KEVIN BENTLEY PHONE NO : 585 8696669 7796 VICTOR-MENDON RD SE DECISION MADE: 15-SEP-16 VICTOR NY 14564 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Noiselezz FIRMA INGEMARSSON 510(k) NO: K160531(Abbreviated) ATTN: Natashia Ingemarsson-MatzenPHONE NO : 45 36 177050 VILVORDEVEJ 61 SE DECISION MADE: 01-SEP-16 CHARLOTTENLUND DK 2920 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Enseal X1 Large Jaw Tissue Sealer ETHICON ENDO-SURGERY, LLC 510(k) NO: K160554(Traditional) ATTN: DAVID LOCKE PHONE NO : 513 3371281 4545 CREEK RD SE DECISION MADE: 09-SEP-16 CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CareSens Pen Needle, Softip Pen Needle YIDOBIO INC. 510(k) NO: K160575(Traditional) ATTN: KYUNG HEE YOON PHONE NO : 82 31 3525035 #3-1, 59-12, DONG4-GIL, HYANGNAM-ESE DECISION MADE: 07-SEP-16 HWASEONG-SI KR 18624 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WiCap Athena GTX 510(k) NO: K160582(Abbreviated) ATTN: Sean Mahoney PHONE NO : 515 2883360 103 5900 NW 86th Street, Suite 300 SE DECISION MADE: 02-SEP-16 Johnston IA 50131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Indy OTW Vascular Retriever COOK INCORPORATED 510(k) NO: K160593(Traditional) ATTN: Chad Schulenburg PHONE NO : 812 3353575 104073 750 DANIELS WAY SE DECISION MADE: 02-SEP-16 BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BC-5D Hematology Control R & D SYSTEMS, INC. 510(k) NO: K160606(Traditional) ATTN: RAVI KOMMINENI PHONE NO : 612 6564463 614 MCKINLEY ST NE SE DECISION MADE: 01-SEP-16 MINNEAPOLIS MN 55413 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Invacare Platinum Mobile Oxygen Concentrator INVACARE CORPORATION 510(k) NO: K160630(Traditional) ATTN: ELIJAH N. WREH PHONE NO : 440 3296840 ONE INVACARE WAY SE DECISION MADE: 27-SEP-16 ELYRIA OH 44035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASS XS Spinal System MEDICREA INTERNATIONAL S.A. 510(k) NO: K160640(Traditional) ATTN: David Ryan PHONE NO : 33 472 018787 14 PORTE DU GRAND LYON SE DECISION MADE: 23-SEP-16 NEYRON FR 01700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube BECTON, DICKINSON AND COMPANY 510(k) NO: K160657(Traditional) ATTN: Branden Reid PHONE NO : 201 8477378 1 BECTON DRIVE SE DECISION MADE: 23-SEP-16 FRANKLIN LAKES NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LigaPASS MEDICREA INTERNATIONAL S.A. 510(k) NO: K160698(Traditional) ATTN: DAVID RYAN PHONE NO : 33 472 018787 14 PORTE DU GRAND LYON SE DECISION MADE: 02-SEP-16 NEYRON FR 01700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves Haylard Health 510(k) NO: K160709(Abbreviated) ATTN: Gwendolyn George PHONE NO : 520 6642822 5405 Windward Parkway SE DECISION MADE: 06-SEP-16 Alpharetta GA 30004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K160724(Traditional) ATTN: KATHLEEN DRAY-LYONS PHONE NO : 781 8264551 500 GBC DRIVE SE DECISION MADE: 07-SEP-16 NEWARK DE 19714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NutraStim Hair Laser Helmet NUTRA LUXE MD LLC 510(k) NO: K160728(Traditional) ATTN: GLORIA AVENDANO PHONE NO : 239 5619699 12801 COMMONWEALTH DR. UNIT 2-6 SE DECISION MADE: 16-SEP-16 FORT MYERS FL 33976 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CATSmart FRESENIUS KABI AG 510(k) NO: K160735(Traditional) ATTN: Barry G. Hicks PHONE NO : 49 6172 6860 ELSE-KRONER-STRASSE 1 SE DECISION MADE: 16-SEP-16 Bad Homburg DE 61352 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) VENCLOSE, INC. 510(k) NO: K160754(Traditional) ATTN: MAI LY WILCOX PHONE NO : 415 2541930 2570 N. 1ST., 2ND FL #221 SE DECISION MADE: 09-SEP-16 SAN JOSE CA 95131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Procellera VOMARIS INNOVATIONS, INC. 510(k) NO: K160783(Traditional) ATTN: Timothy Joiner PHONE NO : 480 9214948 1911 E. 5TH ST SE DECISION MADE: 07-SEP-16 Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAM Titanium Blanks ALTATEC GMBH 510(k) NO: K160784(Traditional) ATTN: COLLEEN BOSWELL PHONE NO : 49 7044 94450 MAYBACHSTRASSE 5 SE DECISION MADE: 14-SEP-16 WIMSHEIM DE D-71299 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) NEXMED TECHNOLOGY CO., LTD 510(k) NO: K160816(Traditional) ATTN: Ellen Xu PHONE NO : 86 755 29481701 2 FLOOR OF NO.1 BUILDING, JIA AN SE DECISION MADE: 21-SEP-16 Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERRAD® NX Sterilizer with ALLClear™ Technology ADVANCED STERILIZATION PRODUCTS 510(k) NO: K160818(Traditional) ATTN: Jamie Byun PHONE NO : 949 7882067 33 Technology Drive SE DECISION MADE: 27-SEP-16 Irvine CA 92617 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV RESMED LTD 510(k) NO: K160822(Traditional) ATTN: JASJIT BAVEJA PHONE NO : 61 88841000 1 ELIZABETH MACARTHUR DRIVE SE DECISION MADE: 09-SEP-16 BELLA VISTA AU 2153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology DENTSPLY SIRONA 510(k) NO: K160825(Traditional) ATTN: Helen Lewis PHONE NO : 717 4871332 221 WEST PHILADELPHIA STREET SUITESE DECISION MADE: 27-SEP-16 York PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Dentium Implantium & SuperLine Prosthetics DENTIUM CO., LTD. 510(k) NO: K160828(Abbreviated) ATTN: Sangpil Yoon PHONE NO : 82 312 072200 150, EONDONG-RO, GIHEUNG-GU SE DECISION MADE: 15-SEP-16 Yongin-si KR 443-270 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MiniMed Quick-serter MEDTRONIC MINIMED 510(k) NO: K160860(Traditional) ATTN: Noreen Bajwa PHONE NO : 818 5765224 18000 DEVONSHIRE STREET SE DECISION MADE: 22-SEP-16 NORTHRIDGE CA 91325 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AirStrip RPM AirStrip Technologies, Inc. 510(k) NO: K160862(Traditional) ATTN: Andy Miller PHONE NO : 335 E. Sonterra Blvd, Suite 200 SE DECISION MADE: 19-SEP-16 San Antonio TX 78258 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pavati Z40.2 Zirconia CCRI, INC. 510(k) NO: K160867(Traditional) ATTN: ROBIN CARDEN PHONE NO : 949 3665221 1319 CALLE AVANZADO SE DECISION MADE: 12-SEP-16 SAN CLEMENTE CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Photonica Professional Ward Photonics LLC 510(k) NO: K160880(Traditional) ATTN: Terry Ward PHONE NO : 800 3925950 1980 N Atlantic Avenue SE DECISION MADE: 23-SEP-16 Cocoa Beach FL 32931 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERRAD 100NX Sterilizer with ALLClearTM Technology ADVANCED STERILIZATION PRODUCTS 510(k) NO: K160903(Traditional) ATTN: JAMIE BYUN PHONE NO : 949 7882067 33 TECHNOLOGY DRIVE SE DECISION MADE: 26-SEP-16 Irvine CA 92617 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Hansen Medical Magellan Robotic Catheter 9Fr HANSEN MEDICAL, INC. 510(k) NO: K160919(Traditional) ATTN: MARYSA LOUSTALOT PHONE NO : 650 4045824 800 E MIDDLEFIELD ROAD SE DECISION MADE: 20-SEP-16 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Endophys Blood Pressure Monitor ENDOPHYS HOLDINGS, LLC 510(k) NO: K160945(Traditional) ATTN: Rebecca K. Pine PHONE NO : 760 8095178 1601 ELM STREET SE DECISION MADE: 26-SEP-16 Dallas TX 75201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CDB Self Ligating Bracket 8F CDB CORPORATION 510(k) NO: K160957(Traditional) ATTN: YANNIRE THOMPSON PHONE NO : 910 3836464 9201 INDUSTRIAL BOULEVARD, NE SE DECISION MADE: 27-SEP-16 LELAND NC 28451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Battalion Universal Spacer System ALPHATEC SPINE 510(k) NO: K160958(Traditional) ATTN: MARY FUNK PHONE NO : 760 4946840 5818 EL CAMINO REAL SE DECISION MADE: 08-SEP-16 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Neodent Implant System - Titanium Base for CEREC JJGC INDUSTRIA E COMERCIO DE MATER510(k) NO: K160964(Traditional) ATTN: JACSON Cambruzzi PHONE NO : 55 412 1694058 AV. JUSCELINO KUBITSCHEK DE OLIVEISE DECISION MADE: 16-SEP-16 CURITIBA BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Aprima Smartesis Centesis Pump COOK INCORPORATED 510(k) NO: K161002(Traditional) ATTN: ERUM B. NASIR PHONE NO : 812 3353575 102607 750 DANIELS WAY SE DECISION MADE: 28-SEP-16 BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Self-retaining Retractor FETZER MEDICAL GMBH & CO.KG 510(k) NO: K161004(Traditional) ATTN: Harald Jung PHONE NO : 49 7462 94799182 UNTER BUCHSTEIG 5 SE DECISION MADE: 09-SEP-16 Tuttlingen DE 78532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NuVasive® Reline® System NUVASIVE, INCORPORATED 510(k) NO: K161014(Special) ATTN: Thao Huynh PHONE NO : 858 3205256 7475 LUSK BOULEVARD SE DECISION MADE: 28-SEP-16 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Profound System SYNERON CANDELA CORPORATION 510(k) NO: K161043(Traditional) ATTN: Ruthie Amir PHONE NO : 508 3587400 330 530 BOSTON POST ROAD SE DECISION MADE: 12-SEP-16 Wayland MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: All-Bond Universal w/BAC (not finalized) Bisco, Inc. 510(k) NO: K161051(Traditional) ATTN: Ryan Hobson PHONE NO : 847 5346143 1100 West Irving Park Road SE DECISION MADE: 09-SEP-16 Schaumburg IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EzRay Air (Model VEX-P300) Vatech Co., Ltd 510(k) NO: K161063(Traditional) ATTN: Daniel Kim PHONE NO : 82 31 3799492 13, Samsung 1-ro 2-gil SE DECISION MADE: 01-SEP-16 Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” EGINEERED TISSUE SOLUTIONS, LLC 510(k) NO: K161067(Traditional) ATTN: Mark Borden PHONE NO : 573 4585966 4030 HYPOINT NORTH SE DECISION MADE: 15-SEP-16 Rolla MO 65401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ahead 300 BRAINSCOPE COMPANY INC 510(k) NO: K161068(Traditional) ATTN: Michael Singer PHONE NO : 240 7527677 4350 East West Highway Suite 1050 SE DECISION MADE: 22-SEP-16 Bethesda MD 20814 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SeaSpine Shoreline ACS - Anterior Cervical Standalone System SEASPINE ORTHOPEDICS CORPORATION 510(k) NO: K161081(Traditional) ATTN: Michelle Willis PHONE NO : 760 2165104 5770 ARMADA DRIVE SE DECISION MADE: 14-SEP-16 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) Sterilmed, Inc. 510(k) NO: K161086(Traditional) ATTN: Patricia Kaufman PHONE NO : 763 4883211 5010 Cheshire Parkway, Suite 2 SE DECISION MADE: 20-SEP-16 Plymouth MN 55446 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KARL STORZ Flexible Video-Neuro-Endoscope System KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K161112(Traditional) ATTN: SUSIE S. CHEN PHONE NO : 424 2188201 2151 E. GRAND AVENUE SE DECISION MADE: 17-SEP-16 EL SEGUNDO CA 90245 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PILLAR SA PTC ORTHOFIX INC. 510(k) NO: K161129(Traditional) ATTN: Natalia Volosen PHONE NO : 214 9372145 3451 PLANO PARKWAY SE DECISION MADE: 08-SEP-16 LEWISVILLE TX 75056 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Spinal fixation system CANWELL MEDICAL CO., LTD. 510(k) NO: K161151(Traditional) ATTN: CHEN HUI PHONE NO : 86 579 89008253 NO. 466 SOUTH XIANHUA STREET,HIGH-SE DECISION MADE: 21-SEP-16 JINHUA CN 321016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra ELLIPSE A/S 510(k) NO: K161162(Traditional) ATTN: OLE KOFOD PHONE NO : 45 4 5176863 AGERN ALLE 11 SE DECISION MADE: 16-SEP-16 HOERSHOLM DK DK-2970 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Next Science Irrigation Solution NEXT SCIENCE, LLC 510(k) NO: K161165(Traditional) ATTN: MATTHEW MYNTTI PHONE NO : 855 5642762 8130 BAYMEADOWS WAY WEST, SUITE 20SE DECISION MADE: 07-SEP-16 JACKSONVILLE FL 33256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: StageOne Select Cement Spacer Molds for Temporary Hip Replacement BIOMET, INC. 510(k) NO: K161166(Traditional) ATTN: Carmen Albany PHONE NO : 574 3713024 56 EAST BELL DRIVE SE DECISION MADE: 08-SEP-16 Warsaw IN 46581 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MyLabSix Ultrasound System Esaote Europe B.V. 510(k) NO: K161168(Traditional) ATTN: Bert Vorstenbosch PHONE NO : 011 31 433824600 Philipsweg 1 SE DECISION MADE: 02-SEP-16 Maastricht NL 6227 AJ 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Avenue® T TLIF Cage LDR SPINE USA, INC. 510(k) NO: K161173(Traditional) ATTN: JOHN ROSSMAN PHONE NO : 512 7958306 13785 RESEARCH BLVD, SUITE 200 SE DECISION MADE: 28-SEP-16 AUSTIN TX 78750 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUCERNA Dental Laser VIAX DENTAL LAB 510(k) NO: K161185(Traditional) ATTN: EDWIN M. FIRST PHONE NO : 949 6333554 CALLE POTRERILLOS, FLEXIPARK BODSE DECISION MADE: 26-SEP-16 ALAJUELA CR 20108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs ECO MEDI GLOVE SDN BHD 510(k) NO: K161187(Traditional) ATTN: Suresh Kumar PHONE NO : 603 60283033 Lot 23826, Jalan TEmbaga Kuning, KSE DECISION MADE: 09-SEP-16 Taiping MY 34600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ClearRead CT RIVERAIN TECHNOLOGIES, LLC 510(k) NO: K161201(Traditional) ATTN: Jennifer Butsch PHONE NO : 937 4256811 3020 SOUTH TECH BLVD. SE DECISION MADE: 09-SEP-16 Miamisburg OH 45324 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Atteris Antimicrobial Skin Protectant ROCHAL INDUSTRIES LLC 510(k) NO: K161212(Traditional) ATTN: William J. Coulston PHONE NO : 210 8706534 12719 CRANES MILL SE DECISION MADE: 30-SEP-16 SAN ANTONIO TX 78230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit HALYARD HEALTH 510(k) NO: K161232(Traditional) ATTN: GWENDOLYN GEORGE PHONE NO : 520 2046442 5405 WINDWARD PARKWAY SE DECISION MADE: 30-SEP-16 ALPHARETTA GA 30004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MTA2.2 MATERIAL AVALON BIOMED INC. 510(k) NO: K161239(Traditional) ATTN: CAROLYN PRIMUS PHONE NO : 941 8969948 1912 44TH AVE E SE DECISION MADE: 01-SEP-16 BRADENTON FL 34203 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Super Distal Access (SDA) INNEUROCO, INC 510(k) NO: K161262(Traditional) ATTN: Marc Litzenberg PHONE NO : 954 4725988 4635 NW 103RD AVENUE SE DECISION MADE: 19-SEP-16 Sunrise FL 33351 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OptoMonitor II Opsens Inc 510(k) NO: K161263(Traditional) ATTN: Vanessa Mootoosamy PHONE NO : 418 781 03333401 750, Boulevard du Parc TechnologiqSE DECISION MADE: 13-SEP-16 Quebec CA GIP 4S3 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Compound W Wart Removal System Dual Power MEDTECH PRODUCTS INC. 510(k) NO: K161294(Traditional) ATTN: JEAN BOYKO PHONE NO : 914 5246894 660 WHITE PLAINS ROAD SE DECISION MADE: 15-SEP-16 Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sysmex Automated Blood Coagulation Analyzer CS-2100i SIEMENS HEALTHCARE DIAGNOSTICS PRO510(k) NO: K161312(Traditional) ATTN: NILS NEUMANN PHONE NO : 49 64 21397133 EMIL-VON-BEHRING-STR. 76 SE DECISION MADE: 01-SEP-16 MARBURG DE 35041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sysmex Automated Blood Coagulation Analyzer CS-5100 Siemens Healthcare Diagnostics Pro510(k) NO: K161317(Traditional) ATTN: Nils Neumann PHONE NO : 49 642 1397133 Emil-von-Behring-Str. 76 SE DECISION MADE: 02-SEP-16 Marburg DE 35041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMG Pink Nitrile Examination Glove Powder Free ECO MEDI GLOVE SDN. BHD. 510(k) NO: K161320(Traditional) ATTN: Suresh Kumar PHONE NO : 60 3 60283033 LOT 23826, JALAN TEMBAGA KUNING, SE DECISION MADE: 01-SEP-16 TAIPING MY 34600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GentleCath Glide Intermittent Catheter CONVATEC LIMITED 510(k) NO: K161344(Traditional) ATTN: ELINOR JONES PHONE NO : 44 01244 854176 GDC, FIRST AVENUE, DEESIDE INDUSTRSE DECISION MADE: 20-SEP-16 DEESIDE GB CH5 2NU 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Signia sterilization tray COVIDIEN 510(k) NO: K161347(Traditional) ATTN: KATHERINE Y. CHOI PHONE NO : 203 4928412 60 MIDDLETOWN AVENUE SE DECISION MADE: 07-SEP-16 NORTH HAVEN CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Matrix LS-40 CO2 Laser System SHANGHAI WONDERFUL OPTO-ELECTRICS 510(k) NO: K161356(Traditional) ATTN: Amy Lee PHONE NO : 86 21 62642623 2F, BUILDING 3 LANE 561, NUJIANG RSE DECISION MADE: 09-SEP-16 SHANGHAI CN 200333 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) Agfa HealthCare N.V. 510(k) NO: K161368(Traditional) ATTN: Koen Vervoort PHONE NO : 32 3 4447368 Septestraat 27 SE DECISION MADE: 22-SEP-16 Mortsel BE B-2640 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELSA Spacers GLOBUS MEDICAL, INC. 510(k) NO: K161379(Traditional) ATTN: KELLY J. BAKER PHONE NO : 610 9301800 1670 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 29-SEP-16 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable Shockwave Medical, Inc. 510(k) NO: K161384(Traditional) ATTN: NORA HADDING PHONE NO : 510 2793068 48501 Warm Springs Blvd, Suite 108SE DECISION MADE: 14-SEP-16 Fremont CA 94539 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Elation Pulmonary Balloon Dilation MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K161392(Traditional) ATTN: DAVID THOMAS PHONE NO : 801 3164956 1600 WEST MERIT PARKWAY SE DECISION MADE: 01-SEP-16 SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Navident ClaroNav Inc. 510(k) NO: K161406(Traditional) ATTN: Doron Dekel PHONE NO : 647 9511525 1140 Sheppard Avenue West, Unit 10SE DECISION MADE: 08-SEP-16 Toronto CA M3K 2A2 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Phasix Mesh C.R. BARD INC. 510(k) NO: K161424(Traditional) ATTN: JANNA BABSON PHONE NO : 401 8258454 100 CROSSINGS BOULEVARD SE DECISION MADE: 29-SEP-16 WARWICK RI 02886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-CUBE 11 ALPINION MEDICAL SYSTEMS CO., LTD.510(k) NO: K161439(Traditional) ATTN: DONGHWAN KIM PHONE NO : 82 70 74652068 1FL AND 6FL VERDI TOWER, 72, DIGITSE DECISION MADE: 21-SEP-16 SEOUL KR 08393 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NuVasive® CoRoent® Small Interlock™ System NUVASIVE INCORPORATED 510(k) NO: K161442(Traditional) ATTN: Cynthia Adams PHONE NO : 858 320 4549 7475 LUSK BOULEVARD SE DECISION MADE: 28-SEP-16 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Biopor Porous Polyethylene Implants Ceremed , Inc. 510(k) NO: K161446(Traditional) ATTN: Chelsea Mitchell PHONE NO : 310 8152125 3643 Lenawee Ave SE DECISION MADE: 27-SEP-16 Los Angeles CA 90016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIB Stent Placement Catheter NUMED, INC. 510(k) NO: K161451(Traditional) ATTN: Nichelle LaFlesh PHONE NO : 315 3284491 2880 MAIN ST. SE DECISION MADE: 22-SEP-16 HOPKINTON NY 12965 510(k) STATEMENT DEVICE: Catalys Precision Laser System Optimedica Corporation 510(k) NO: K161455(Traditional) ATTN: Ankur Kaushal PHONE NO : 408 7928207 1310 Moffet Park Drive SE DECISION MADE: 20-SEP-16 Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) VARIAN MEDICAL SYSTEMS, X-RAY PROD510(k) NO: K161459(Traditional) ATTN: Catherine Mulcahy PHONE NO : 315 2346800 121 METROPOLITAN DRIVE SE DECISION MADE: 06-SEP-16 LIVERPOOL NY 13088 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters Innovative Health, LLC 510(k) NO: K161464(Traditional) ATTN: Rafal Chudzik PHONE NO : 480 5256006 1435 North Hayden Road, Suite 100 SE DECISION MADE: 30-SEP-16 Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CardioConfirm MORTARA INSTRUMENT, INC. 510(k) NO: K161465(Traditional) ATTN: Margaret Mucha PHONE NO : 414 3541600 7865 NORTH 86TH STREET SE DECISION MADE: 03-SEP-16 Milwaukee WI 53224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Xenco Medical Posterior Cervical System Xenco Medical, LLC 510(k) NO: K161478(Traditional) ATTN: Gustavo Prado PHONE NO : 858 2021505 9930 Mesa Rim Road SE DECISION MADE: 06-SEP-16 San Diego CA 92121 510(k) STATEMENT DEVICE: Nanovis Intervertebral Body Fusion System and Forticore(R) NANOVIS LLC 510(k) NO: K161485(Traditional) ATTN: MATTHEW HEDRICK PHONE NO : 877 9076266 5865 EAST STATE RD. 14 SE DECISION MADE: 06-SEP-16 COLUMBIA CITY IN 46725 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VPAP Adapt SV, VPAP Tx, S9 VPAP Tx ResMed Ltd 510(k) NO: K161487(Traditional) ATTN: Jasjit Baveja PHONE NO : 61 2 88841518 1 Elizabeth Macarthur Drive SE DECISION MADE: 09-SEP-16 Bella Vista AU NSW 2153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Syntorr K-wire and Pin System SYNTORR INC 510(k) NO: K161489(Traditional) ATTN: DANIEL MARTIN PHONE NO : 650 8670367 1157 HARKER AVENUE SE DECISION MADE: 16-SEP-16 PALO ALTO CA 94301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Penumbra Aspiration System Penumbra, Inc. 510(k) NO: K161506(Traditional) ATTN: Richard Kimura PHONE NO : 510 9952034 1 Penumbra Place SE DECISION MADE: 26-SEP-16 Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NeuroStar TMS Therapy System NEURONETICS, INC. 510(k) NO: K161519(Traditional) ATTN: JUDY P. WAYS PHONE NO : 610 6404202 3222 PHOENIXVILLE PIKE SE DECISION MADE: 11-SEP-16 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Tangis Anterior Cervical Plate NVISION BIOMEDICAL TECHNOLOGIES, L510(k) NO: K161524(Traditional) ATTN: DIANA L. LANGHAM PHONE NO : 210 5453713 1350 N LOOP 1604 E, SUITE 103 SE DECISION MADE: 02-SEP-16 SAN ANTONIO TX 78232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SeaSpine® NewPort™ Spinal System SEASPINE ORTHOPEDICS CORPORATION 510(k) NO: K161535(Traditional) ATTN: Michelle Willis PHONE NO : 760 2165104 5770 ARMADA DRIVE SE DECISION MADE: 08-SEP-16 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TR-100 BTL INDUSTRIES, INC. 510(k) NO: K161551(Traditional) ATTN: Jan Zarsky PHONE NO : 866 2851656 47 LORING DRIVE SE DECISION MADE: 13-SEP-16 FRAMINGHAM MA 01702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sound Options Tinnitus Treatment Sound Options Tinnitus Treatments 510(k) NO: K161562(Traditional) ATTN: Michael Chrostowski PHONE NO : 416 8015356 3841 Ridgepoint Way SE DECISION MADE: 28-SEP-16 Mississauga CA L5N 7T7 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUO STETIC MEDICAL AESTHETICS DEVELOPM510(k) NO: K161565(Traditional) ATTN: Juan Ye PHONE NO : 86 755 61218197 10-11th Floor, Bensi Building, NewSE DECISION MADE: 01-SEP-16 Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGNA Voyager GE HEALTHCARE 510(k) NO: K161567(Traditional) ATTN: Glen Sabin PHONE NO : 262 5216848 3200 N. GRANDVIEW BLVD SE DECISION MADE: 01-SEP-16 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Bone Solutions Mixing and Delivery System BONE SOLUTIONS, INC. 510(k) NO: K161568(Traditional) ATTN: DREW DIAZ PHONE NO : 817 8098850 5712 COLLEYVILLE BLVD, SUITE 210 SE DECISION MADE: 16-SEP-16 COLLEYVILLE TX 76034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FilmArray RP EZ Control Panel M265 MAINE MOLECULAR QUALITY CONTROLS, 510(k) NO: K161573(Traditional) ATTN: JOAN GORDON PHONE NO : 207 8851072 23 MILL BROOK ROAD SE DECISION MADE: 02-SEP-16 SACO ME 04072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Arthrex Synergy RF System ARTHREX, INC. 510(k) NO: K161581(Traditional) ATTN: William Heard PHONE NO : 239 6435553 71813 1370 Creekside Blvd SE DECISION MADE: 09-SEP-16 Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Mano and Mano Personal Lubricant Mano and Mano Proprietary Limited 510(k) NO: K161585(Traditional) ATTN: Katrina Allen PHONE NO : 613 9555 1318 286 Chesterville Road SE DECISION MADE: 06-SEP-16 Moorabbin AU 3189 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments GLOBUS MEDICAL INC. 510(k) NO: K161591(Traditional) ATTN: Kelly J. Baker PHONE NO : 610 9301800 1670 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 21-SEP-16 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Resection Electrodes OLYMPUS WINTER & IBE GMBH 510(k) NO: K161600(Traditional) ATTN: Katharina Campbell PHONE NO : 49 406 69662997 KUEHNSTRASSE 61 SE DECISION MADE: 06-SEP-16 Hamburg DE 22045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Arctic Sun Temperature Management System Medivance, Inc. 510(k) NO: K161602(Special) ATTN: Stacci Cronk PHONE NO : 303 3215151 321 South Taylor Ave, Suite 200 SE DECISION MADE: 02-SEP-16 Louisville CO 80027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: InterForm Cervical Interbody Cage System NEXT ORTHOSURGICAL 510(k) NO: K161608(Traditional) ATTN: ELLEN YARNALL PHONE NO : 760 2953600 3270 CORPORATE VIEW SUITE A SE DECISION MADE: 30-SEP-16 Vista CA 92081 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PixelShine ALGOMEDICA 510(k) NO: K161625(Traditional) ATTN: Jagdish Vij PHONE NO : 650 7149944 2600 EL CAMINO REAL, SUITE 100 SE DECISION MADE: 19-SEP-16 Palo Alto CA 94306 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Provicol QM Plus VOCO GMBH 510(k) NO: K161630(Traditional) ATTN: TH. PLAUMANN PHONE NO : 49 472 17190 ANTON-FLETTNER-STR. 1-3 SE DECISION MADE: 15-SEP-16 CUXHAVEN DE 27472 510(k) STATEMENT DEVICE: Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor AMBU A/S 510(k) NO: K161656(Special) ATTN: CAMILLA WISMAR PHONE NO : 45 7 2252000 BALTORPBAKKEN 13 SE DECISION MADE: 01-SEP-16 BALLERUP DK DK-2750 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Anexa Wound Flush, Sterile Water & Sterile Normal Saline ANEXA BIOMEDICAL, INC. 510(k) NO: K161658(Traditional) ATTN: LENNY BUDLOO PHONE NO : 813 7807927 40423 AIR TIME AVE SE DECISION MADE: 14-SEP-16 ZEPHYRHILLS FL 33542 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ponto 3, Ponto 3 Power and Ponto 3 SuperPower OTICON MEDICAL AB 510(k) NO: K161671(Traditional) ATTN: Satu Hjartstam PHONE NO : 46 735 449813 DATAVAGEN 37B SE DECISION MADE: 29-SEP-16 ASKIM SE SE-436 32 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SpeediCath Flex Coude Coloplast Corp. 510(k) NO: K161672(Traditional) ATTN: Rebecca S. Roberts PHONE NO : 612 3442373 1601 West River Road North SE DECISION MADE: 29-SEP-16 Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Madsen Zodiac GN OTOMETRICS 510(k) NO: K161707(Special) ATTN: Asif Muhammad PHONE NO : 847 5342150 Hoerskaetten 9 SE DECISION MADE: 01-SEP-16 Taatrup DK DK-2630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Personal Kinetigraph (PKG) System GKC MANUFACTURING PTY LTD. 510(k) NO: K161717(Traditional) ATTN: BRENDAN FAFIANI PHONE NO : 61 459 999582 LEVEL 15, 440 COLLINS ST SE DECISION MADE: 20-SEP-16 MELBOURNE AU 3000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set Diazyme Laboratories 510(k) NO: K161721(Traditional) ATTN: Abhijit Datta PHONE NO : 858 4554762 12889 Gregg Court SE DECISION MADE: 20-SEP-16 Poway CA 92130 510(k) STATEMENT DEVICE: Symmetry Sharp Kerrison Rongeur Symmetry Surgical Inc. 510(k) NO: K161744(Special) ATTN: Lora Tjomstol PHONE NO : 1 800 2513000 3034 Owen Drive SE DECISION MADE: 07-SEP-16 Antioch TN 37013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARIX Hand System Jeil Medical Corporation 510(k) NO: K161746(Special) ATTN: Seungyong Lee PHONE NO : 82 2 8503533 SE DECISION MADE: 21-SEP-16 Seoul KR 152-728 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGEC® Spinal Bracing and Distraction System NUVASIVE SPECIALIZED ORTHOPEDICS, 510(k) NO: K161751(Traditional) ATTN: REBECCA SHELBURNE WALKER PHONE NO : 949 8373600 101 ENTERPRISE, SUITE 100 SE DECISION MADE: 02-SEP-16 ALISO VIEJO CA 92656 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SyncVision System Volcano Corporation 510(k) NO: K161756(Traditional) ATTN: Elaine Alan PHONE NO : 858 7641281 3721 Valley Ctr. Dr. SE DECISION MADE: 05-SEP-16 San Diego CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Weck Auto Endo10 Automatic Endoscopic Clip Applier TELEFLEX MEDICAL 510(k) NO: K161758(Traditional) ATTN: HOLLY HALLOCK PHONE NO : 919 4334996 3015 CARRINGTON MILL BLVD SE DECISION MADE: 07-SEP-16 MORRISVILLE NC 27560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CG+ Arrow JACC ARROW INTERNATIONAL, INC. (SUBSIDI510(k) NO: K161765(Special) ATTN: JULIE LAWSON PHONE NO : 610 3780131 2400 BERNVILLE ROAD SE DECISION MADE: 06-SEP-16 READING PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: i-Sil SPIDENT Co., Ltd. 510(k) NO: K161774(Traditional) ATTN: J. M. Ahn PHONE NO : 82 32 8194570 203 & 312, Korea Indsutrial CompleSE DECISION MADE: 30-SEP-16 Incheon KR 21692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PINPOINT Endoscopic Fluorescence Imaging System Novadaq Technologies Inc. 510(k) NO: K161792(Special) ATTN: Jen Pendlebury PHONE NO : 905 6293822 205 8329 Eastlake Drive, Unit 101 SE DECISION MADE: 20-SEP-16 Burnaby CA V5A 4W2 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Traxcess .007 Mini Guidewire MICROVENTION, INC. 510(k) NO: K161803(Special) ATTN: SAPNA SINGH PHONE NO : 714 2478162 1311 VALENCIA AVENUE SE DECISION MADE: 30-SEP-16 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LigaSure Retractable L-Hook Laparoscopic Sealer/Divider COVIDIEN 510(k) NO: K161804(Traditional) ATTN: DAWN D. TINDALL PHONE NO : 303 5817034 5920 LONGBOW DRIVE SE DECISION MADE: 16-SEP-16 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Solana Influenza A+B Assay Quidel Corporation 510(k) NO: K161814(Traditional) ATTN: Ronald H. Lollar PHONE NO : 740 5893373 2005 East State Street, Suite 100 SE DECISION MADE: 27-SEP-16 Athens OH 45701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEM Premier 3000 Instrumentation Laboratory Co. 510(k) NO: K161818(Special) ATTN: Nikita Malladi PHONE NO : 781 6743245 180 Hartwell Road SE DECISION MADE: 14-SEP-16 Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PK AIM GYRUS ACMI INC. 510(k) NO: K161825(Traditional) ATTN: GRAHAM A.L. BAILLIE PHONE NO : 508 8042690 136 TURNPIKE ROAD SE DECISION MADE: 26-SEP-16 SOUTHBOROUGH MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: O2VENT T OVENTUS MANUFACTURING PTY LTD 510(k) NO: K161832(Special) ATTN: HEMANGI MALDE PHONE NO : 61 7 31803196 1 SWANN ROAD SE DECISION MADE: 23-SEP-16 INDOOROOPILLY AU 4068 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Xenocor Xenoscope Laparoscopic System Xenocor, Inc 510(k) NO: K161838(Traditional) ATTN: Spencer Walker PHONE NO : 801 5815080 630 Komas Dr. Suite 200 SE DECISION MADE: 26-SEP-16 Salt Lake City UT 84108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K161843(Traditional) ATTN: PAUL BIGGINS PHONE NO : 714 6697808 1385 SHIMOISHIGAMI SE DECISION MADE: 21-SEP-16 OTAWARA-SHI JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BioFlo Midline Catheter NAVILYST MEDICAL, INC. 510(k) NO: K161866(Traditional) ATTN: ROBIN FULLER PHONE NO : 508 6587986 26 FOREST STREET SE DECISION MADE: 08-SEP-16 MARLBOROUGH MA 07152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LaserCap300, LaserCap224, LaserCap120, LaserCap80 TRANSDERMAL CAP, INC. 510(k) NO: K161875(Traditional) ATTN: MICHAEL RABIN PHONE NO : 440 2411846 938 CHESTNUT RUN SE DECISION MADE: 30-SEP-16 GATES MILLS OH 44040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Tritium® Sternal Cable Plate System Pioneer Surgical Technology, Inc. 510(k) NO: K161876(Special) ATTN: Sarah Pleaugh PHONE NO : 906 2269909 375 River Park Circle SE DECISION MADE: 09-SEP-16 Marquette MI 49855 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTAGE System Baylis Medical Company Inc. 510(k) NO: K161878(Traditional) ATTN: Meghal Khakhar PHONE NO : 905 6024875 2645 Matheson Blvd. East SE DECISION MADE: 26-SEP-16 Mississauga CA L4W 5S4 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Solitaire Platinum Revascularization Device Micro Therapeutics, Inc. d/b/a ev3510(k) NO: K161879(Special) ATTN: Ryan Kenney PHONE NO : 949 2975489 9775 Toledo Way SE DECISION MADE: 21-SEP-16 Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip Volcano Corporation 510(k) NO: K161887(Special) ATTN: Brian Park PHONE NO : 858 7204176 3721 Valley Centre Drive Suite 50SE DECISION MADE: 20-SEP-16 San Diego CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JULIET® LL Lateral Lumbar Cage SPINEART 510(k) NO: K161888(Special) ATTN: FRANCK PENNESI PHONE NO : 41 225 701246 INTERNATIONAL CENTER COINTRIN 20 RSE DECISION MADE: 12-SEP-16 Geneva CH 1215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 2MP Color LCD Monitor CCL214 (CL21214) JVC KENWOOD Corporation 510(k) NO: K161895(Traditional) ATTN: Tsukasa Tashiro PHONE NO : 81 258 246611 3-12, Moriya-cho, Kanagawa-ku SE DECISION MADE: 08-SEP-16 Yokohama JP 221-0022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant CHURCH & DWIGHT CO.,INC. 510(k) NO: K161915(Traditional) ATTN: Lisa Burns PHONE NO : 609 8061200 500 CHARLES EWING BLVD SE DECISION MADE: 09-SEP-16 EWING NJ 08628 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XP202 3M DEUTSCHLAND GMBH 510(k) NO: K161922(Third Party - Traditional) ATTN: RUEDIGER FRANKE PHONE NO : 49 8152 7001802 ESPE PLATZ SE DECISION MADE: 01-SEP-16 SEEFELD DE 82229 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Guidewire 0.6 Single Use FIGON GMBH 510(k) NO: K161940(Special) ATTN: Dirk Mucha PHONE NO : 49 3302 2012110 NEUENDORFSTR 23B SE DECISION MADE: 18-SEP-16 Hennigsdorf DE 16761 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector PERKINELMER, INC. 510(k) NO: K161942(Special) ATTN: Dawn Spooner PHONE NO : 781 6636071 940 WINTER STREET SE DECISION MADE: 01-SEP-16 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm) ENCORE MEDICAL, L.P. 510(k) NO: K161945(Special) ATTN: TEFFANY HUTTO PHONE NO : 512 8346255 9800 METRIC BLVD. SE DECISION MADE: 23-SEP-16 AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DoseCHECK Sun Nuclear Corporation 510(k) NO: K161946(Traditional) ATTN: Rene' Hardee PHONE NO : 321 2596862 2304 3275 Suntree Blvd. SE DECISION MADE: 16-SEP-16 Melbourne FL 32940 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Monoject Enteral Syringe with ENFit Connector COVIDIEN 510(k) NO: K161963(Traditional) ATTN: SONA MANICKAM PHONE NO : 508 2618147 15 HAMPSHIRE STREET SE DECISION MADE: 01-SEP-16 MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector PerkinElmer, Inc. 510(k) NO: K161966(Special) ATTN: Dawn Spooner PHONE NO : 781 6636071 940 Winter Street SE DECISION MADE: 08-SEP-16 Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Interlocked Circular Small Field Collimators, Elekta Integrated AKTINA MEDICAL CORPORATION 510(k) NO: K161984(Traditional) ATTN: TONY SPACCAROTELLA PHONE NO : 845 2680101 18 360 NORTH ROUTE 9W SE DECISION MADE: 27-SEP-16 CONGERS NY 10920 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K161992(Special) ATTN: JENNIFER SIEGEL PHONE NO : 609 2750500 311 ENTERPRISE DRIVE SE DECISION MADE: 22-SEP-16 PLAINSBORO NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Aerin Medical Stylus Aerin Medical, Inc. 510(k) NO: K161994(Special) ATTN: Scott Wolf PHONE NO : 650 4343247 690 W. Fremont Avenue, Unit 3 SE DECISION MADE: 22-SEP-16 Sunnyvale CA 94087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JiveX VISUS TECHNOLOGY TRANSFER GMBH 510(k) NO: K162008(Traditional) ATTN: AXEL SCHREIBER PHONE NO : 49 234 936930 Universitaetsstrasse 136 SE DECISION MADE: 16-SEP-16 Bochum DE 44799 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARESCAPE Central Station V2 GE HEALTHCARE 510(k) NO: K162012(Special) ATTN: ROBERT CASARSA PHONE NO : 414 3623063 8200 WEST TOWER AVE. SE DECISION MADE: 15-SEP-16 MILWAUKEE WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Eusol-C AL.CHI.MI.A. S.r.l. 510(k) NO: K162013(Special) ATTN: Mauro Beccaro PHONE NO : 39 049 896207464 Viale Austria 14 SE DECISION MADE: 15-SEP-16 Ponte San Nicolo IT 35020 510(k) STATEMENT DEVICE: Affinity NT Oxygenator with Cortiva BioActive Surface MEDTRONIC, INC. 510(k) NO: K162016(Traditional) ATTN: RENEE CVEYKUS PHONE NO : 763 5053059 8200 CORAL SEA STREET NE (MVS83) SE DECISION MADE: 21-SEP-16 MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated COVIDIEN 510(k) NO: K162047(Special) ATTN: CELSO DURAN PHONE NO : 303 5306445 5920 LONGBOW DRIVE SE DECISION MADE: 15-SEP-16 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PhotonBlade Invuity Inc. 510(k) NO: K162053(Traditional) ATTN: John Kang PHONE NO : 415 6552160 444 De Haro Street SE DECISION MADE: 15-SEP-16 San Francisco CA 94107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZEE RETRIEVAL GENICON, INC 510(k) NO: K162059(Special) ATTN: KATLYN KACHMAN PHONE NO : 407 6574851 6869 STAPOINT COURT SUITE 114 SE DECISION MADE: 29-SEP-16 WINTER PARK FL 32792 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRILLIUM Oval Head Coil 32 HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K162079(Traditional) ATTN: DOUG THISTLETHWAITE PHONE NO : 330 4251313 1959 SUMMIT COMMERCE PARK SE DECISION MADE: 16-SEP-16 TWINSBURG OH 44087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TPH Spectra+ Universal Composite Restorative DENTSPLY SIRONA 510(k) NO: K162107(Traditional) ATTN: HELEN LEWIS PHONE NO : 717 4871332 221 W PHILADELPHIA ST, SUITE 60 SE DECISION MADE: 27-SEP-16 YORK PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORGRIP NG/NI Tube Retention System CORPAK MedSystems, Inc. a Division510(k) NO: K162110(Traditional) ATTN: Stephanie Wasielewski PHONE NO : 847 4033484 1001 Asbury Dr SE DECISION MADE: 15-SEP-16 Buffalo Grove IL 60089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAAS MRV Pie Medical Imaging BV 510(k) NO: K162112(Traditional) ATTN: Annemiek Bouts PHONE NO : 31 43 3281328 Philipsweg 1 SE DECISION MADE: 21-SEP-16 Maastricht NL 6227 AJ 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW) ArthoCare Corporation 510(k) NO: K162126(Traditional) ATTN: Ashley M. Johnson PHONE NO : 512 3585762 7000 West William Cannon Drive SE DECISION MADE: 29-SEP-16 Austin TX 78735 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Restore PACS XIAN WINGSPAN ELECTRONIC TECHNOLOG510(k) NO: K162141(Traditional) ATTN: Echo Chou PHONE NO : 86 159 29949205 Rm. A608, Pioneering Square, No. 4SE DECISION MADE: 02-SEP-16 Xi'an CN 710075 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FixxSure® X-Link INNOVASIS, INC. 510(k) NO: K162143(Traditional) ATTN: MARSHALL MCCARTY PHONE NO : 801 2612236 614 EAST 3900 SOUTH SE DECISION MADE: 23-SEP-16 SALT LAKE CITY UT 84107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBit Series Diagnostic Ultrasound System CHISON MEDICAL IMAGING CO., LTD. 510(k) NO: K162172(Traditional) ATTN: QIFEI LIU PHONE NO : 0086 510 85311707 NO.228, CHANGJIANG EAST ROAD, BLOCSE DECISION MADE: 14-SEP-16 WUXI CN 214142 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: dS FootAnkle I6CH 1.5T Coil Invivo Corporation 510(k) NO: K162177(Third Party - Traditional) ATTN: Ken Revennaugh PHONE NO : 352 3848590 3545 SW 47th Ave. SE DECISION MADE: 14-SEP-16 Gainesville FL 32608 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CareView 1500P X-ray Flat Panel Detectors CARERAY DIGITAL MEDICAL SYSTEM CO.510(k) NO: K162178(Special) ATTN: XU WEI PHONE NO : 86 512 86860288 109 B3-501, BIOBAY,218 XINGHU STREET SSE DECISION MADE: 01-SEP-16 SuZhou CN 215123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Edwards eSheath Introducer Set Edward Lifesciences 510(k) NO: K162184(Special) ATTN: Yi Gao PHONE NO : 949 2502295 1 Edward Way SE DECISION MADE: 02-SEP-16 Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Xario 100 Diagnostic Ultrasound System, V5.0 Toshiba Medical Systems Corporatio510(k) NO: K162187(Traditional) ATTN: Paul Biggins PHONE NO : 714 6697808 1385 Shimoishigami SE DECISION MADE: 30-SEP-16 Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) VR MEDICAL TECHNOLOGY 510(k) NO: K162188(Traditional) ATTN: LEE PAN PHONE NO : 86 512 57200050 90 GAOXIN ROAD, ZHOUZHANG SE DECISION MADE: 22-SEP-16 KUNSHAN CN 215325 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TSolution One Cup1 Surgical System THINK SURGICAL INC. 510(k) NO: K162195(Special) ATTN: IN K. MUN PHONE NO : 510 2492300 47320 MISSION FALLS COURT SE DECISION MADE: 14-SEP-16 FREMONT CA 94539 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUSON SC2000 Diagnostic Ultrasound System Siemens Medical Solutions Inc. Ult510(k) NO: K162221(Third Party - Special) ATTN: Kevon Kong PHONE NO : 650 9699112 685 East Middlefield Road SE DECISION MADE: 06-SEP-16 Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GENflex2 Total Knee System StelKast, Inc. 510(k) NO: K162222(Special) ATTN: Dave Stumpo PHONE NO : 724 7312208 200 Hidden Valley Road SE DECISION MADE: 07-SEP-16 McMurray PA 15317 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ArtPix Mobile EZ2GO CMT MEDICAL TECHNOLOGIES, LTD. 510(k) NO: K162224(Special) ATTN: LILIA SCHLOSBERG PHONE NO : 972 485 66220 HACARMEL ST. BLD 7/2, POB 111 INDUSE DECISION MADE: 22-SEP-16 YOQNEAM ILIT IL 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TorqVue Low Profile Delivery Catheter AGA MEDICAL CORPORATION (WHOLLY OW510(k) NO: K162228(Special) ATTN: Mary Johnson PHONE NO : 651 7562213 5050 NATHAN LANE SE DECISION MADE: 09-SEP-16 PLYMOUTH MN 55442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System Siemens Medical Solutions, Inc. 510(k) NO: K162243(Third Party - Traditional) ATTN: Shelly Pearce PHONE NO : 650 2790134 685 E MIDDLEFIELD RD SE DECISION MADE: 06-SEP-16 Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Cascadia Interbody System K2M, Inc. 510(k) NO: K162264(Special) ATTN: NANCY GIEZEN PHONE NO : 571 9192000 600 HOPE PARKWAY SE SE DECISION MADE: 21-SEP-16 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K162267(Special) ATTN: Zhai Pei PHONE NO : 0086 0755 81885604 MINDRAY BUILDING, KEJI 12TH RD S, SE DECISION MADE: 06-SEP-16 SHENZHEN CN 518057 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SonoSite iViz Ultrasound System FUJIFILM SONOSITE, INC. 510(k) NO: K162288(Third Party - Abbreviated) ATTN: Patricia Liau PHONE NO : 425 9516870 21919 30TH DRIVE SE SE DECISION MADE: 08-SEP-16 Bothell WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SomnoDent ALPHA SomnoMed Inc. 510(k) NO: K162306(Third Party - Abbreviated) ATTN: Kien Nguyen PHONE NO : 972 3773400 101 7460 Warren Pkwy Ste 190 SE DECISION MADE: 20-SEP-16 Frisco TX 75034 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: OrthoPediatrics Locking Proximal Femur System Cortical Screws ORTHOPEDIATRICS, CORP. 510(k) NO: K162307(Special) ATTN: ADAM CARGILL PHONE NO : 574 2686379 2850 FRONTIER DRIVE SE DECISION MADE: 27-SEP-16 WARSAW IN 46582 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System Philips Healthcare 510(k) NO: K162329(Third Party - Traditional) ATTN: Maxs Newberry PHONE NO : 425 4828810 22100 Bothell Everett Highway SE DECISION MADE: 14-SEP-16 Bothell WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Nexcore GI Insufflator NEXCORE TECHNOLOGY, LLC 510(k) NO: K162332(Third Party - Traditional) ATTN: Julie Broderick PHONE NO : 781 254 5094 P.O. Box 903 SE DECISION MADE: 29-SEP-16 Winchester MA 01890 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Symbia 6.5 SIEMENS MEDICAL SOLUTIONS, USA, IN510(k) NO: K162337(Special) ATTN: Cynthia Busch PHONE NO : 847 3047095 2501 N. BARRINGTON ROAD SE DECISION MADE: 08-SEP-16 Hoffman Estates IL 60192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Full Automatic (NIBP) Blood Pressure Monitor HEALTH & LIFE CO., LTD. 510(k) NO: K162338(Special) ATTN: SARAH SU PHONE NO : 886 282 271300 1201 9F, NO.186, JIAN YI ROAD SE DECISION MADE: 21-SEP-16 ZHONGHE DISTRICT, NEW TAIPEI CITY 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Scenium SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K162339(Special) ATTN: VERONICA PADHARIA PHONE NO : 630 8775761 810 INNOVATION DRIVE SE DECISION MADE: 21-SEP-16 KNOXVILLE TN 37932 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge NEOTRACT, INC. 510(k) NO: K162345(Special) ATTN: LOUIS-PIERRE MARCOUX PHONE NO : 925 2018861 4473 WILLOW ROAD, SUITE 100 SE DECISION MADE: 21-SEP-16 PLEASANTON CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Surefire Guiding Catheter Surefire Medical, Inc. 510(k) NO: K162359(Third Party - Special) ATTN: Lynne Aronson PHONE NO : 720 3059877 6272 W. 91st Avenue SE DECISION MADE: 21-SEP-16 Westminster CO 80031 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PowerGlide Pro Midline Catheter C.R. BARD, INC. 510(k) NO: K162377(Special) ATTN: JACOB LEE PHONE NO : 801 5225823 605 NORTH 5600 WEST SE DECISION MADE: 22-SEP-16 SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TrailBlazer Angled Support Catheter Medtronic Vascular, Inc.(formerly 510(k) NO: K162384(Third Party - Traditional) ATTN: David Robertson PHONE NO : 763 3987000 3033 Campus Dr SE DECISION MADE: 22-SEP-16 Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: da Vinci Xi 12 – 8 mm Reducer Intuitive Surgical, Inc. 510(k) NO: K162411(Special) ATTN: Vishal Kanani PHONE NO : 408 5232035 1266 Kifer Road SE DECISION MADE: 21-SEP-16 Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IRIDEX Cyclo G6 Laser System, G-Probe Illuminate IRIDEX CORPORATION 510(k) NO: K162416(Special) ATTN: KATHY MAYNOR PHONE NO : 650 6058772 1212 TERRA BELLA AVENUE SE DECISION MADE: 29-SEP-16 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Acuson Freestyle Ultrasound System Siemens Medical Solutions, Inc. 510(k) NO: K162417(Third Party - Traditional) ATTN: Lawrence Engle PHONE NO : 610 8341220 102 5168 Campus Drive SE DECISION MADE: 28-SEP-16 Plymouth Meeting PA 19462 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: nva, nvp, and nvt NVISION BIOMEDICAL TECHNOLOGIES, L510(k) NO: K162426(Special) ATTN: Diana L. Langham PHONE NO : 210 5453713 1350 N LOOP 1604 E, SUITE 103 SE DECISION MADE: 29-SEP-16 SAN ANTONIO TX 78232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: mi-eye 2, mi-eye 2 monitor Trice Medical 510(k) NO: K162475(Special) ATTN: Tiffini Diage PHONE NO : 608 9898080 1000 Continental Dr. Suite 240 SE DECISION MADE: 16-SEP-16 King of Prussia PA 19406 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR EIZO CORPORATION 510(k) NO: K162497(Traditional) ATTN: Hiroaki Hashimoto PHONE NO : 81 76 2742468 153 SHIMOKASHIWANO SE DECISION MADE: 19-SEP-16 HAKUSAN JP 924-8566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 8MP Color LCD Monitor (C81W+) Shenzhen Beacon Display Technology510(k) NO: K162527(Traditional) ATTN: Fu Ailing PHONE NO : 86 0755 33985118 5150 12F, Block B1, Nanshan Zhiyuan, NoSE DECISION MADE: 30-SEP-16 Shenzhen CN 518055 510(k) SUMMARY AVAILABLE FROM FDA
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