510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD January 2017 TOTAL 510(k)s THIS PERIOD 222 TOTAL WITH SUMMARIES 203 TOTAL WITH STATEMENTS 19 DEVICE: Love Alchemy's Love Lotion LOVE ALCHEMY LLC 510(k) NO: K151857(Traditional) ATTN: Eric Weiss PHONE NO : 421 KINGSLEY AVE #200 SE DECISION MADE: 09-JAN-17 ORANGE PARK FL 32073 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Kolplast Cervical Sample Collection Kit KOLPLAST CI SA 510(k) NO: K153128(Traditional) ATTN: DANIELA FERACIN PHONE NO : 55 11 49610972 ESTRADA MUNICIPAL IVA 136. NO 418.SE DECISION MADE: 13-JAN-17 ITUPEVA- SP BR 13295-000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Caremed Reusable & Disposable SPO2 Sensors SHENZHEN CAREMED MEDICAL TECHNOLOG510(k) NO: K153184(Traditional) ATTN: XINLIN XIAO PHONE NO : 86 755 2714369 ZONE B, 3/F, 11 BUILDING, HEBEI INSE DECISION MADE: 04-JAN-17 SHENZHEN CN 518021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Taps for Resorbable Screws SYNTHES (USA) PRODUCTS LLC 510(k) NO: K153587(Traditional) ATTN: Susan Lewandowski PHONE NO : 610 7195852 1301 Goshen Parkway SE DECISION MADE: 18-JAN-17 West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Lympha-Flow(LF1200) DaeSung Maref Co., Ltd 510(k) NO: K160178(Special) ATTN: Jae-wha Lee PHONE NO : 82 31 4597211 298-24, Gongdan-ro SE DECISION MADE: 11-JAN-17 Gunpo-si KR 15809 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AGNES GOWOONSESANG COSMETICS CO., LTD 510(k) NO: K160469(Traditional) ATTN: Kyeong Tai Ko PHONE NO : 82 31 7249009 (Seohyeon-dong, 4, 5F Cocoplaza), SE DECISION MADE: 05-JAN-17 Seongnam-si KR 463-824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Medline Non-Surgical Isolation Gown- MEDLINE INDUSTRIES, INC. 510(k) NO: K160471(Traditional) ATTN: PAULINE MARALIT PHONE NO : 847 9492283 ONE MEDLINE PLACE SE DECISION MADE: 31-JAN-17 MUNDELEIN IL 60060 510(k) STATEMENT DEVICE: Chaorum Implant System MEDIMECCA CO., LTD. 510(k) NO: K160536(Traditional) ATTN: PARK YOUNG WAN PHONE NO : 82 285 68282 DAERYUNG TECHNO TOWN 3-CHA 104, 10SE DECISION MADE: 05-JAN-17 SEOUL KR 153-772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe CERTA DOSE, INC. 510(k) NO: K160589(Traditional) ATTN: SARAH HANSSEN PHONE NO : 858 3495906 573 RACE STREET SE DECISION MADE: 19-JAN-17 DEVER CO 80206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: D.O.R.C. Disposable Cryo Probe DUTCH OPHTHALMIC RESEARCH CENTER I510(k) NO: K160591(Traditional) ATTN: DANIELLE SLEEGERS PHONE NO : 31 181 458080 SCHEIJDELVEWEG 2 SE DECISION MADE: 23-JAN-17 ZUIDLAND NL 3214 VN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Medline Waste Station Medline Industries, Inc. 510(k) NO: K160660(Traditional) ATTN: Matt Clausen PHONE NO : 847 6434785 One Medline Place SE DECISION MADE: 19-JAN-17 Mundelein IL 60060 510(k) STATEMENT DEVICE: SuperLine DENTIUM CO., LTD. 510(k) NO: K160965(Abbreviated) ATTN: YOUNJUNG YUK PHONE NO : 82 250 18560 29 TEHERAN-RO, 87-GZL GANGNAM-GU SE DECISION MADE: 13-JAN-17 SEOUL KR 446-518 510(k) STATEMENT DEVICE: Altus Spine Interbody Fusion System ALTUS PARTNERS, LLC 510(k) NO: K160976(Traditional) ATTN: Claudia Hill PHONE NO : 610 3554156 5149 WEST CHESTER PIKE SE DECISION MADE: 25-JAN-17 Newtown Square PA 19073 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Neo GBR System NEOBIOTECH CO., LTD. 510(k) NO: K160991(Traditional) ATTN: In Ho Kim PHONE NO : 82 2 5822885 #312-2,36, Digital-ro 27 gil, GuroSE DECISION MADE: 10-JAN-17 Seoul KR 08381 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Hospira Extension Set, Hospira Primary Set HOSPIRA, INC. 510(k) NO: K161036(Traditional) ATTN: CHARLES NEITZEL PHONE NO : 224 2126087 375 FIELD DRIVE SE DECISION MADE: 06-JAN-17 LAKE FOREST IL 60045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cranial PSI OSSDSIGN AB 510(k) NO: K161090(Traditional) ATTN: ULRIK BIRGERSSON PHONE NO : 46 0 18553993 VIRDINGS ALLE 2 SE DECISION MADE: 19-JAN-17 UPPSALA SE SE 754 50 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STIMPOD NMS460 Nerve Stimulator XAVANT TECHNOLOGY (PTY) LTD 510(k) NO: K161091(Traditional) ATTN: Roche Janse van Rensberg PHONE NO : 27 0 277435959 Unit 102 The Tannery Industrial PaSE DECISION MADE: 18-JAN-17 Silverton ZA 0184 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PANPAC DISPOSABLE VACUUM CURETTES PANPAC MEDICAL CORPORATION 510(k) NO: K161106(Traditional) ATTN: YEN-MING PAN PHONE NO : 886 2 86472242 6F-1,2, NO. 202, SEC.3, TA-TONG ROSE DECISION MADE: 13-JAN-17 SHI-CHIH DIST. TW 22103 510(k) STATEMENT DEVICE: IDS-iSYS Intact PTHN IMMUNODIAGNOSTIC SYSTEMS LTD 510(k) NO: K161158(Traditional) ATTN: CHRIS PRICE PHONE NO : 44 019 15190660 10 DIDCOT WAY BOLDON BUSINESS PARKSE DECISION MADE: 31-JAN-17 BOLDON GB Ne35 9pd 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: da Vinci Xi Surgical System Intuitive Surgical, Inc. 510(k) NO: K161178(Traditional) ATTN: Brandon Hansen PHONE NO : 408 5232100 1266 Kifer Road SE DECISION MADE: 19-JAN-17 Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C2 Cryoballoon Ablation System C2 THERAPEUTICS, INC. 510(k) NO: K161202(Traditional) ATTN: Theresa Brandner-Allen PHONE NO : 650 5215921 303 CONVENTION WAY, SUITE 1 SE DECISION MADE: 05-JAN-17 Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOCAM Flex HD Camera System 5521 RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K161204(Traditional) ATTN: MIKE LOITERMAN PHONE NO : 847 9131113 353 CORPORATE WOODS PARKWAY SE DECISION MADE: 11-JAN-17 VERNON HILL IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL) bioMerieux, Inc. 510(k) NO: K161217(Traditional) ATTN: Karen Russell PHONE NO : 314 7318639 595 Anglum Road SE DECISION MADE: 12-JAN-17 Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Zmaxx T Series Maxx Digm, Inc. 510(k) NO: K161219(Traditional) ATTN: Keith Jew PHONE NO : 408 4629608 3265 Kifer Road SE DECISION MADE: 26-JAN-17 Santa Clara CA 95051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Facilis™ Spinal System BAUI BIOTECH CO., LTD. 510(k) NO: K161231(Traditional) ATTN: BETTY YEN PHONE NO : 886 289 769538 154 6F., NO.8, SEC.1 ZHONGXING RD., WUSE DECISION MADE: 23-JAN-17 NEW TAIPEI CITY TW 24872 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Universa Firm Ureteral Stents and Stent Sets COOK INCORPORATED 510(k) NO: K161236(Traditional) ATTN: JAMIE RIDNER PHONE NO : 812 3353575 102834 750 DANIELS WAY SE DECISION MADE: 27-JAN-17 BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: meso-relle (AAL34, AAL36, AM30G) BIOTEKNE SRL 510(k) NO: K161255(Traditional) ATTN: Fabio Tassi PHONE NO : 39 051 565211 VIA DELLA BASTIA 9 SE DECISION MADE: 19-JAN-17 CASALECCHIO DI RENO IT 40033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CephSimulation ANATOMAGE, INC 510(k) NO: K161270(Traditional) ATTN: Changxin Xu PHONE NO : 408 8851474 108 111N. MARKET ST, #500 SE DECISION MADE: 04-JAN-17 SAN JOSE CA 95113 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis Biomet, Inc. 510(k) NO: K161273(Traditional) ATTN: Carmen Albany PHONE NO : 574 3713024 56 East Bell Drive SE DECISION MADE: 25-JAN-17 Warsaw IN 46581 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Bondiloxs Topical Hemostatic Granules MEDTRADE PRODUCTS LTD. 510(k) NO: K161274(Traditional) ATTN: Andrew Whitton PHONE NO : 44 1270 503868 ELECTRA HOUSE CREWE BUSINESS PARK SE DECISION MADE: 18-JAN-17 CREWE GB CW1 6GL 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip RESEARCH INSTRUMENTS LIMITED 510(k) NO: K161275(Traditional) ATTN: Wendy Hassan PHONE NO : 44 132 6372753 BICKLAND INDUSTRIAL PARK SE DECISION MADE: 23-JAN-17 FALMOUTH GB TR11 4TA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Dentalis Bio Solution Implants DENTALIS BIO SOLUTION IMPLANTS LLC510(k) NO: K161281(Traditional) ATTN: Osnat Yanai PHONE NO : 347 7753350 2801 FORTUNE CIRCLE E, SUITE B SE DECISION MADE: 11-JAN-17 Indianapolis IN 46241 510(k) STATEMENT DEVICE: dynaMX™ Compression Plate MX ORTHOPEDICS, CORP. 510(k) NO: K161303(Traditional) ATTN: Howard L. Schrayer PHONE NO : 617 2078604 1050 WALTHAM STREET Suite 510 SE DECISION MADE: 26-JAN-17 LEXINGTON MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cantab Mobile CAMBRIDGE COGNITION LTD., US AGENT510(k) NO: K161328(Traditional) ATTN: Nancy D. Clementi PHONE NO : 610 5272600 TUNBRIDGE COURT, TUNBRIDGE LANE SE DECISION MADE: 13-JAN-17 Bottisham GB CB25 9TU 510(k) STATEMENT DEVICE: F&P Brevida™ Nasal Pillows Mask Fisher & Paykel Healthcare Ltd. 510(k) NO: K161412(Traditional) ATTN: Amelia Ortiz PHONE NO : 64 9 5740100 15 Maurice Paykel Place, East TamaSE DECISION MADE: 18-JAN-17 Auckland NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Anatomic Total Knee System AMPLITUDE 510(k) NO: K161414(Traditional) ATTN: MIREILLE LEMERY PHONE NO : 33 475 813495 11 COURS JACQUES OFFENBACH SE DECISION MADE: 19-JAN-17 VALENCE FR 26000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set CARDINAL HEALTH 510(k) NO: K161418(Traditional) ATTN: Judith Harbour PHONE NO : 847 8872325 1500 S Waukegan Rd SE DECISION MADE: 19-JAN-17 Waukegan IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SureClip(TM) Repositionable Hemostasis Clip Micro-Tech (Nanjing) CO., Ltd. 510(k) NO: K161463(Traditional) ATTN: Becky Li PHONE NO : 86 25 58646378 NO. 10 Gaoke Third Road SE DECISION MADE: 06-JAN-17 Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System ORTHOFIX SRL 510(k) NO: K161466(Traditional) ATTN: Gianluca Ricadona PHONE NO : 39 045 6719000 VIA DELLE NAZIONI 9 SE DECISION MADE: 24-JAN-17 BUSSOLENGO (VR) IT 37012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Juno VPAP ST-A ResMed Ltd 510(k) NO: K161492(Traditional) ATTN: Jean-Nicolas Boudaud PHONE NO : 61 2 88841000 1 Elizabeth Macarthur Drive SE DECISION MADE: 19-JAN-17 Bella Vista AU 2153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray COOK INCORPORATED 510(k) NO: K161504(Special) ATTN: Steven Lawrie PHONE NO : 812 3353575 104518 750 DANIELS WAY SE DECISION MADE: 06-JAN-17 BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ceruloplasmin BECKMAN COULTER IRELAND INC. 510(k) NO: K161508(Traditional) ATTN: MARGUERITA SWEENEY PHONE NO : 353 65 6831495 LISMEEHAN O' CALLAGHAN'S, MILLS SE DECISION MADE: 09-JAN-17 CO. CLARE IE 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Precision Thin Reciprocating Blade, 0.010in. STRYKER CORPORATION 510(k) NO: K161514(Traditional) ATTN: Joanna McCarthy PHONE NO : 011 353 21453296 4100 E. MILHAM AVE SE DECISION MADE: 17-JAN-17 KALAMAZOO MI 49009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Mortara Surveyor Patient Monitor MORTARA INSTRUMENT, INC. 510(k) NO: K161517(Traditional) ATTN: SARAH WEBER PHONE NO : 414 3541600 7865 NORTH 86TH STREET SE DECISION MADE: 11-JAN-17 MILWAUKEE WI 53224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EasyOne Air Spirometer NDD MEDIZINTECHNIK AG 510(k) NO: K161536(Traditional) ATTN: JERRY MASIELLO PHONE NO : 41 44 4452530 TECHNOPARKSTRASSE 1 SE DECISION MADE: 05-JAN-17 ZURICH CH 8005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GMI Frontier Dental Implant System ILERIMPLANT S.L. 510(k) NO: K161593(Traditional) ATTN: ANTONIO COSO PHONE NO : 34 973 184350 C/ ENGINYER MIES, 705-B SE DECISION MADE: 19-JAN-17 LLEIDA ES 25191 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Poseidon OCT Spinal Fixation System Medyssey USA, Inc. 510(k) NO: K161637(Traditional) ATTN: Shawn Kim PHONE NO : 847 4270200 1550 E. Higgins Road, Suite 123 SE DECISION MADE: 05-JAN-17 Elk Grove Village IL 60007 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOSPA IS ACP System CORENTEC CO., LTD 510(k) NO: K161641(Traditional) ATTN: J.S. DANIEL PHONE NO : 82 41 5857144 12, YEONGSANHONG 1-GIL, IPJANG-MYESE DECISION MADE: 05-JAN-17 CHEONAN-SI KR 31056 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Polysmith Sleep System, Model NTI7593 Neurotronics, Inc. 510(k) NO: K161650(Traditional) ATTN: David Pezet PHONE NO : 352 3729955 3600 NW 43rd Street, STE F1 SE DECISION MADE: 19-JAN-17 Gainesville FL 32606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: F&P InfoSmart FISHER & PAYKEL HEALTHCARE LTD. 510(k) NO: K161686(Traditional) ATTN: Jayanti Karandikar PHONE NO : 64 095 740100 15 MAURICE PAYKEL PLACE SE DECISION MADE: 24-JAN-17 East Tamaki NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Advanced Gynecological Applicator NUCLETRON BV 510(k) NO: K161688(Traditional) ATTN: RUDOLF VOS PHONE NO : 31 318 557133 WAARDGELDER 1 SE DECISION MADE: 27-JAN-17 VEENENDAAL NL 3905 TH 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DynaMatrix/Dynamatrix Plus COOK BIOTECH INCORPORATED 510(k) NO: K161762(Special) ATTN: Perry W. Guinn PHONE NO : 765 4973355 1425 INNOVATION PLACE SE DECISION MADE: 13-JAN-17 West Lafayette IN 47906 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Philips IntelliVue GuardianSoftware PHILIPS MEDIZIN SYSTEME BOEBLINGEN510(k) NO: K161767(Traditional) ATTN: Michael Asmalsky PHONE NO : 49 7031 4631277 HEWLETT-PACKARD STR. 2 SE DECISION MADE: 27-JAN-17 BOEBLINGEN DE 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs WRP ASIA PACIFIC SDN BHD 510(k) NO: K161823(Traditional) ATTN: SARALA DEVI JAYARAMAN PHONE NO : 60 387 061486 LOT 1, JALAN 3, KAW PERUSAHAAN BANSE DECISION MADE: 23-JAN-17 SEPANG MY 43900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: D2P 3D SYSTEMS, INC. 510(k) NO: K161841(Traditional) ATTN: KIM TORLUEMKE PHONE NO : 972 3 9114206 CORNER OF GOLAN AND HANEGEV STREETSE DECISION MADE: 09-JAN-17 AIRPORT CITY IL 70151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Meridian M110 Fetal Monitoring System MINDCHILD MEDICAL 510(k) NO: K161902(Traditional) ATTN: JIM ROBERTSON PHONE NO : 978 9751160 1600 OSGOOD STREET #2-17 SE DECISION MADE: 12-JAN-17 NORTH ANDOVER MA 01845 510(k) STATEMENT DEVICE: GEO Bone Screw System GRAMERCY EXTREMITY ORTHOPEIDICS, L510(k) NO: K161904(Traditional) ATTN: MICHAEL P. SIMPSON PHONE NO : 1239 N. GLENVILLE DR. SE DECISION MADE: 18-JAN-17 RICHARDSON TX 75081 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OsteoCool V-3 RF Ablation System Baylis Medical Company Inc. 510(k) NO: K161949(Traditional) ATTN: Meghal Khakhar PHONE NO : 905 6024875 2645 Matheson Blvd. East SE DECISION MADE: 31-JAN-17 Mississauga CA L4W 5S4 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm Callisyn Biomedical, Inc. 510(k) NO: K161967(Traditional) ATTN: Shallwei Sun PHONE NO : 978 6870596 260 Candlestick Road SE DECISION MADE: 27-JAN-17 North Andover MA 01845 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Bindex BI-2 BONE INDEX FINLAND, LTD. 510(k) NO: K161971(Abbreviated) ATTN: Janne Karjalainen PHONE NO : 358 40 7079892 MICROKATU 1 SE DECISION MADE: 09-JAN-17 KUOPIO FI 70211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OBS Electrosurgical Generator (Model: OBS-350A) Baisheng Medical Co.,Ltd. 510(k) NO: K162034(Third Party - Traditional) ATTN: Peter Mao PHONE NO : 86 750 6628113 809 No.11 Fusheng Road, Xinhui DistricSE DECISION MADE: 30-JAN-17 Jiangmen CN 529100 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Acclarix LX8 Diagnostic Ultrasound System EDAN INSTRUMENTS INC 510(k) NO: K162055(Traditional) ATTN: Alice Yang PHONE NO : 86 755 26858736 3/F - B, NANSHAN MEDICAL EQUIPMENTSE DECISION MADE: 31-JAN-17 SHENZHEN CN 518067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ConceptoMed Luer-Jack Slip 10ml ConceptoMed AS 510(k) NO: K162057(Traditional) ATTN: Marit Martinsen PHONE NO : 47 760 89000 Hattvikveien 2 SE DECISION MADE: 11-JAN-17 Ballstad NO N-8373 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CrossBay IVF Embryo Transfer Catheter Set CrossBay Medical Inc. 510(k) NO: K162064(Traditional) ATTN: Piush Vidyarthi PHONE NO : 415 7282847 13240 Evening Creek Drive, Suite 3SE DECISION MADE: 05-JAN-17 San Diego CA 92128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RII Multi-function Infrared Thermometer, Model TH52Z Radiant Innovation Inc. 510(k) NO: K162083(Traditional) ATTN: Monica Chung PHONE NO : 886 3 6111666 1F, No.3 Industrial E. 9th Rd. SciSE DECISION MADE: 09-JAN-17 HsinChu TW 30075 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOTO Partial Knee System Medacta International SA 510(k) NO: K162084(Traditional) ATTN: Stefano Baj PHONE NO : 41 91 6966060 Strada Regina SE DECISION MADE: 03-JAN-17 Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MultiStim ECO PAJUNK GmbH Medizintechnologie 510(k) NO: K162086(Traditional) ATTN: Christian Quass PHONE NO : 490 7704 9291586 Karl-Hall-Str. 1 SE DECISION MADE: 06-JAN-17 Geisingen DE 78187 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ecomed Disposable Angiographic Syringes ECOMED SOLUTIONS, LLC 510(k) NO: K162088(Traditional) ATTN: DAVID YUREK PHONE NO : 847 9840106 214 TERRACE DR SE DECISION MADE: 27-JAN-17 MUNDELEIN IL 60060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LED Phototherapy Device LI-TEK ELECTRONIC TECHNOLOGY CORPO510(k) NO: K162098(Traditional) ATTN: Barry Yuan PHONE NO : 86 0769 83117755 NO.8-13, THE INDUSTRIAL PARK OF JISE DECISION MADE: 30-JAN-17 DONGGUAN CN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Siconus SI Joint Fixation System CAMBER SPINE TECHNOLOGIES 510(k) NO: K162121(Traditional) ATTN: DAMIAN HEINZ PHONE NO : 855 8999869 418 E. LANCASTER AVE SE DECISION MADE: 18-JAN-17 WAYNE PA 19087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Fever Scout™ Continuous Monitoring thermometer VivaLnk Inc. 510(k) NO: K162137(Traditional) ATTN: Cecilia Xi PHONE NO : 408 8682898 4655 Old Ironsides Dr. #390 SE DECISION MADE: 19-JAN-17 Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) BRIGHTWAY HOLDINGS SDN BHD. 510(k) NO: K162146(Traditional) ATTN: G. BASKARAN PHONE NO : 603 33431007 LOT 1559, JALAN ISTIMEWA, BATU BELSE DECISION MADE: 05-JAN-17 KLANG MY 42100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord KERR CORPORATION 510(k) NO: K162164(Traditional) ATTN: MOHAMMAD SAAD ANSARI PHONE NO : 909 9625644 1717 W. COLLINS AVE SE DECISION MADE: 13-JAN-17 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Elecsys CYFRA 21-1 CalCheck 5 Roche Diagnostics 510(k) NO: K162173(Traditional) ATTN: Adam Clark PHONE NO : 317 5214371 9115 Hague Road SE DECISION MADE: 12-JAN-17 Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: osteo-WEDGE II ® Open Wedge Bone Locking Plate System GRAHAM MEDICAL TECHNOLOGIES, L.L.C510(k) NO: K162179(Traditional) ATTN: Angela Recchia PHONE NO : 586 6779600 16137 LEONE DRIVE SE DECISION MADE: 10-JAN-17 Macomb MI 48042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set CARDIACASSIST INC. 510(k) NO: K162181(Traditional) ATTN: GREG JOHNSON PHONE NO : 412 9637770 266 240 ALPHA DRIVE SE DECISION MADE: 06-JAN-17 PITTSBURGH PA 15238 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EndoClot EndoClot Plus Co., Ltd. 510(k) NO: K162197(Traditional) ATTN: Hendry Zhang PHONE NO : 086 512 62605550 101 Room, B8 Building, 218 Xinghu SE DECISION MADE: 18-JAN-17 SuZhou CN 215000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Desara TV, Desara Blue TV CALDERA MEDICAL, INC. 510(k) NO: K162201(Traditional) ATTN: Vicki Gail PHONE NO : 818 4837602 5171 CLARETON DRIVE SE DECISION MADE: 11-JAN-17 Agoura Hills CA 91301 510(k) STATEMENT DEVICE: DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent BECKMAN COULTER INC. 510(k) NO: K162208(Traditional) ATTN: Geraldine Fuentespina PHONE NO : 714 9613777 250 S. KRAEMER BLVD. MAIL STOP E1.SE DECISION MADE: 09-JAN-17 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) SUPERVISION OPTIMAX SDN BHD 510(k) NO: K162223(Traditional) ATTN: YAP PEAK GEEH PHONE NO : 60 361 452328 LOT 38, PUTRA INDUSTRIAL PARK, BUKSE DECISION MADE: 04-JAN-17 SUNGAI BULOH MY 40160 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Reliant Multistage Dilatation Balloon Catheter Micro-Tech (Nanjing) CO., Ltd. 510(k) NO: K162226(Traditional) ATTN: Becky Li PHONE NO : 86 25 58646378 NO. 10 Gaoke Third Road SE DECISION MADE: 25-JAN-17 Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Truscope Ultra Patient Monitor GUANGDONG BIOLIGHT MEDITECH CO., L510(k) NO: K162234(Special) ATTN: Jing Liang PHONE NO : 86 756 3399967 INNOVATION FIRST ROAD TECHNOLOGY ISE DECISION MADE: 04-JAN-17 ZHUHAI, CN 519085 510(k) STATEMENT DEVICE: Comfort Flo Humidification System TELEFLEX MEDICAL, INC 510(k) NO: K162242(Traditional) ATTN: BRIAN GALL PHONE NO : 919 2284350 2917 WECK DRIVE SE DECISION MADE: 19-JAN-17 RESEARCH TRIANGLE PARK NC 27709 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Trapper Exchange Device CREGANNA MEDICAL ASLO BUSINESS AS 510(k) NO: K162253(Traditional) ATTN: ORLA HICKEY PHONE NO : 353 917 83438 PARKMORE WEST SE DECISION MADE: 06-JAN-17 GALWAY IE 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERAMAGE UP SHOFU DENTAL CORPORATION 510(k) NO: K162261(Traditional) ATTN: MAURO MALZYNER PHONE NO : 760 7363277 1225 STONE DRIVE SE DECISION MADE: 11-JAN-17 SAN MARCOS CA 92078 510(k) STATEMENT DEVICE: EBM iDO Viewer 1.2.1 EBM Technologies Incorporated 510(k) NO: K162285(Traditional) ATTN: John Su PHONE NO : 808 3976809 5F., No. 516, Sec. 1, Neihu Rd SE DECISION MADE: 27-JAN-17 Taipei TW 114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Tooth Shade Resin Material LIAONING UPCERA CO.,LTD 510(k) NO: K162323(Traditional) ATTN: Charles Shen PHONE NO : 086 24 45565006 NO.122 XIANGHUAI ROAD, ECONOMIC DESE DECISION MADE: 12-JAN-17 BENXI CN 117004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Contour Next EZ Blood Glucose Monitoring System Ascensia Diabetes Care US Inc. 510(k) NO: K162336(Special) ATTN: Jennifer L. Gregory PHONE NO : 574 2563447 430 South Beiger Street SE DECISION MADE: 12-JAN-17 Mishawaka IN 46544 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs HEALTHY GLOVE CO., LTD 510(k) NO: K162381(Traditional) ATTN: Teoh Choh Shee PHONE NO : 66 74 536815 119 Kanchanavanich Road, Tambol PaSE DECISION MADE: 31-JAN-17 Hat Yai TH 90230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: U-IGNITE Bladeless Trocar TIANJIN UWELL MEDICAL DEVICE MANUF510(k) NO: K162387(Traditional) ATTN: TAO FAN PHONE NO : 86 22 58775333 A02, PLANT B, NO. 278, HANGKONG RDSE DECISION MADE: 11-JAN-17 TIANJIN CN 300308 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ET Hybrid Abutment HIOSSEN INC. 510(k) NO: K162390(Traditional) ATTN: David Kim PHONE NO : 888 6780001 85 BEN FAIRLESS DR. SE DECISION MADE: 30-JAN-17 FAIRLESS HILLS PA 19030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Titan 3 Low Speed Angle Attachments DENTALEZ, INC 510(k) NO: K162397(Traditional) ATTN: Dan Laskowitz PHONE NO : 717 2911161 1816 COLONIAL VILLAGE LANE SE DECISION MADE: 19-JAN-17 Lancaster PA 17601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Atellica CH Magnesium (Mg) SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K162399(Traditional) ATTN: LAURA J. DUGGAN PHONE NO : 302 6317654 500 GBC DRIVE, PO BOX 6101 MS 514 SE DECISION MADE: 19-JAN-17 NEWARK DE 19711 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: L300 Go System BIONESS INC. 510(k) NO: K162407(Traditional) ATTN: MERCEDES BAYANI PHONE NO : 661 3626690 25103 RYE CANYON LOOP SE DECISION MADE: 27-JAN-17 VALENCIA CA 91355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Haemonetics Cell Saver Elite/Elite+ Autotransfusion System HAEMONETICS CORPORATION 510(k) NO: K162423(Traditional) ATTN: MARK ANZALONE PHONE NO : 781 3569912 400 WOOD ROAD SE DECISION MADE: 03-JAN-17 BRAINTREE MA 02184 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vado Bi-Directional Steerable Sheath KALILA MEDICAL, INC. 510(k) NO: K162427(Traditional) ATTN: CARRIE NEUBERGER PHONE NO : 415 6403377 745 CAMDEN AVE, SUITE A SE DECISION MADE: 27-JAN-17 CAMPBELL CA 95008-4146 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UniStrip1 Generic Blood Glucose Test Strips OK BIOTECH CO., LTD. 510(k) NO: K162430(Traditional) ATTN: KE-MIN JEN PHONE NO : 886 351 60258 NO.91, SEC.2 GONGDAO 5TH ROAD SE DECISION MADE: 19-JAN-17 HSINCHU CITY TW 30070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Multi-Link X2 ECG Cable and Lead Wire System CAREFUSION 2200 INC. 510(k) NO: K162432(Traditional) ATTN: ERIKA FERNANDEZ PHONE NO : 847 3628097 75 NORTH FAIRWAY DRIVE SE DECISION MADE: 18-JAN-17 VERNON HILLS IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NC Gallant PTCA Catheter MEDINOL LTD. 510(k) NO: K162434(Traditional) ATTN: MICHAL HERSHKOVITZ PHONE NO : 972 3 7679000 KIRYAT ATIDIM, BUILDING 8 SE DECISION MADE: 19-JAN-17 TEL AVIV IL 6158101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Humelock Reversed Shoulder FX SOLUTIONS 510(k) NO: K162455(Traditional) ATTN: Jean-Jacques Martin PHONE NO : 33 4 74553555 1663 RUE DE MAJORNAS SE DECISION MADE: 17-JAN-17 VIRIAT FR 01440 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TrueBeam-TrueBeam STx-Edge Varian Medical Systems, Inc. 510(k) NO: K162472(Traditional) ATTN: Peter J. Coronado PHONE NO : 650 4246320 911 Hansen Way SE DECISION MADE: 19-JAN-17 Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Symbia Intevo Bold SIEMENS MEDICAL SOLUTIONS, USA, IN510(k) NO: K162483(Traditional) ATTN: Cynthia Busch PHONE NO : 847 3047095 2501 N. BARRINGTON ROAD SE DECISION MADE: 09-JAN-17 Hoffman Estates IL 60192-2061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RED Light Device Zhongshan Bisen Plastic Electronic510(k) NO: K162489(Traditional) ATTN: FengPing Li PHONE NO : 86 760 88297142 F2,Bldg1,No.8,Dongzhen North Rd,ZhSE DECISION MADE: 13-JAN-17 Zhong Shan CN 528437 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Disc-FX System ELLIQUENCE LLC 510(k) NO: K162490(Traditional) ATTN: Paul D. Buhrke IV PHONE NO : 516 2779010 2455 Grand Avenue SE DECISION MADE: 06-JAN-17 Baldwin NY 11510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ostial Sprit Cannulae SPYDER MEDICAL 510(k) NO: K162500(Traditional) ATTN: MICHAEL WEBB PHONE NO : 949 5339982 22521 AVENIDA EMPRESA, SUITE 111 SE DECISION MADE: 12-JAN-17 RANCHO SANTA MARGARITA CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LELO RESPECT HEX Natural Rubber Latex Condom LELO INC. 510(k) NO: K162511(Special) ATTN: PAVLE SEDIC PHONE NO : 408 2494000 4320 STEVENS CREEK BLVD., SUITE 20SE DECISION MADE: 13-JAN-17 SAN JOSE CA 95129 510(k) STATEMENT DEVICE: WellDoc BlueStar, WellDoc BlueStar Rx WELLDOC, INC 510(k) NO: K162532(Traditional) ATTN: DANIELLE DORFMAN PHONE NO : 443 6923100 10221 WINCOPIN CIRCLE SUITE 150 SE DECISION MADE: 12-JAN-17 COLUMBIA MD 21044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Turbo-Power (2.0mm) Laser Atherectomy Catheters SPECTRANETICS, INC. 510(k) NO: K162561(Traditional) ATTN: PRISCILA TAPIA PHONE NO : 719 4472587 9965 FEDERAL DRIVE SE DECISION MADE: 05-JAN-17 COLORADO SPRINGS CO 80921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: YOGA Microcatheter CODMAN & SHURTLEFF, INC. 510(k) NO: K162563(Special) ATTN: YOON HEE BEATTY PHONE NO : 305 2652919 325 PARAMOUNT DRIVE SE DECISION MADE: 05-JAN-17 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROCCIA® ACIF SILONY MEDICAL GMBH 510(k) NO: K162587(Traditional) ATTN: Bircan YILMAZ PHONE NO : 49 711 78252540 LEINFELDER STRASSE 60 SE DECISION MADE: 26-JAN-17 Leinfelden-Echterdingen DE 70771 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Elecsys TSH assay, cobas e 801 Immunoassay analyzer ROCHE DIAGNOSTICS 510(k) NO: K162606(Traditional) ATTN: ANGELO PEREIRA PHONE NO : 317 5213544 9115 HAGUE ROAD SE DECISION MADE: 23-JAN-17 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONCORD Plus Radiopaque Bone Cement GLOBUS MEDICAL, INC. 510(k) NO: K162618(Traditional) ATTN: KELLY J. BAKER PHONE NO : 610 9301800 1670 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 23-JAN-17 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERIFY STEAM Integrating Indicator - Short STERIS CORPORATION 510(k) NO: K162631(Traditional) ATTN: TRICIA CREGGER PHONE NO : 440 3927189 5960 HEISLEY ROAD SE DECISION MADE: 27-JAN-17 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Breast BI 7 MR Coil Mammavention 3T MORAS MRI products GmbH 510(k) NO: K162651(Traditional) ATTN: Zahed Sedighiani PHONE NO : 49 931 2992717 Leibnizstr. 4 SE DECISION MADE: 18-JAN-17 Hoechberg DE 97204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A WELL-LIFE HEALTHCARE LIMITED 510(k) NO: K162663(Traditional) ATTN: CHIN-CHIH HSIEH PHONE NO : 886 2 29282112 1F, NO. 16, LANE 454, JUNGJENG ROASE DECISION MADE: 17-JAN-17 YUNGHE DISTRICT, NEW TAIPEI CITY 510(k) STATEMENT DEVICE: Ayers Rock Cervical interbody fusion system Spineway 510(k) NO: K162694(Traditional) ATTN: Nicolas Roth PHONE NO : 330 4 72770152 7 Allee Moulin Berger Ecully FrancSE DECISION MADE: 12-JAN-17 Ecully FR 69130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Axium Prime Detachable Coil System Micro Therapeutics, Inc. d/b/a ev3510(k) NO: K162704(Traditional) ATTN: Joyce Zhong PHONE NO : 949 6801307 9775 Toledo Way SE DECISION MADE: 03-JAN-17 Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit MAINE STANDARDS COMPANY LLC 510(k) NO: K162705(Traditional) ATTN: JAMES CHAMPLIN PHONE NO : 207 8921300 221 US ROUTE 1 SE DECISION MADE: 05-JAN-17 CUMBERLAND FORESIDE ME 04110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREND Vitamin D Test System NanoEnTek USA, Inc. 510(k) NO: K162754(Traditional) ATTN: Jimmy Chen PHONE NO : 925 2250108 5627 Stoneridge Drive Suite 304 SE DECISION MADE: 12-JAN-17 Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Vevazz LED Heat Lamp Vevazz, LLC 510(k) NO: K162763(Traditional) ATTN: Jamie Fettig PHONE NO : 773 6654005 30520 Rancho California Rd, Suite SE DECISION MADE: 05-JAN-17 Temecula CA 92591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JAZZ FRAME SYSTEM IMPLANET S.A. 510(k) NO: K162764(Traditional) ATTN: REGIS LE COUEDIC PHONE NO : 33 557 9955555 TECHNOPOLE BORDEAUX MONTESQUIEU ALSE DECISION MADE: 19-JAN-17 MARTILLAC FR 33650 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Venus Velocity Diode Laser System Venus Concept Ltd. 510(k) NO: K162765(Traditional) ATTN: Tal Bresler-Stramer PHONE NO : 416 9070115 4556 N. Hiatus Road SE DECISION MADE: 11-JAN-17 Sunrise FL 33351 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sentinel BreastScan II System First Sense Medical, LLC 510(k) NO: K162767(Special) ATTN: Alan Alan Klevens PHONE NO : 248 3923006 2001 Centerpoint Parkways, Suite 1SE DECISION MADE: 09-JAN-17 Pontiac MI 48341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Relign System Relign Corporation 510(k) NO: K162770(Traditional) ATTN: Nathan Nguyen PHONE NO : 408 9962517 320 1601 South De Anza Boulevard, SuitSE DECISION MADE: 04-JAN-17 Cupertino CA 95014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Legion Cone System Smith & Nephew, Inc. 510(k) NO: K162775(Traditional) ATTN: Natalie Williams PHONE NO : 901 3995161 7135 Goodlett Farms Parkway SE DECISION MADE: 13-JAN-17 Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASS LP Spinal System MEDICREA INTERNATIONAL S.A 510(k) NO: K162786(Traditional) ATTN: DAVID RYAN PHONE NO : 33 472 018788 14 Z.A PORTE DU GRAND LYON SE DECISION MADE: 25-JAN-17 NEYRON FR 01700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V.A.C.ULTA Negative Pressure Wound Therapy System KCI USA, Inc. (Kinetic Concepts, I510(k) NO: K162790(Traditional) ATTN: Margaret Marsh PHONE NO : 210 2556481 6203 Farinon Drive SE DECISION MADE: 26-JAN-17 San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Barrx Anorectal RFA Wand COVIDIEN LLC 510(k) NO: K162802(Traditional) ATTN: RACHEL SILVA PHONE NO : 408 3287359 15 HAMPSHIRE STREET SE DECISION MADE: 24-JAN-17 MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Akros Fibulink Syndesmosis Repair Kit Akros Medical 510(k) NO: K162805(Traditional) ATTN: Charles Horrell PHONE NO : 248 2595535 3503 Pleasant Green Rd SE DECISION MADE: 10-JAN-17 Durham NC 27705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: InSeca ARC Stylus, Aerin Console Aerin Medical, Inc. 510(k) NO: K162810(Traditional) ATTN: Scott Wolf PHONE NO : 650 4343247 690 W. Fremont Avenue, Unit 3 SE DECISION MADE: 11-JAN-17 Sunnyvale CA 94087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Noddle(TM) IOWA ADAPTIVE TECHNOLOGIES, INC. D510(k) NO: K162817(Traditional) ATTN: R. RIVES BIRD PHONE NO : 319 3825459 2500 CROSSPARK ROAD STE W150 SE DECISION MADE: 18-JAN-17 CORALVILLE IA 52241 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) HARTALEGA SDN. BHD. 510(k) NO: K162818(Traditional) ATTN: KUAN KAM HON PHONE NO : 603 62771733 DATARAN SD PJU 9 SE DECISION MADE: 09-JAN-17 BANDAR SERI DAMANSARA MY 52200 510(k) STATEMENT DEVICE: Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs HARTALEGA SDN. BHD. 510(k) NO: K162819(Traditional) ATTN: KUAN KAM HON PHONE NO : 603 62771733 DATARAN SD PJU 9 SE DECISION MADE: 09-JAN-17 BANDAR SRI DAMANSARA MY 52200 510(k) STATEMENT DEVICE: ASAHI PTCA Guide Wire ASAHI SUOH 03 ASAHI INTECC CO., LTD. 510(k) NO: K162842(Traditional) ATTN: YASUYUKI KAWAHARA PHONE NO : 81 52 7681211 1703 WAKITA-CHO, MORIYAMA-KU SE DECISION MADE: 27-JAN-17 NAGOYA JP 463-0024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: eLyx-PRO Intelligent Sensory Concept SA 510(k) NO: K162851(Traditional) ATTN: Joel Chanteraud PHONE NO : 41 786 514945 Rue du Tasson 3 SE DECISION MADE: 24-JAN-17 SENARCLENS CH 1304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OsteoVation Impact Skeletal Kinetics, LLC. 510(k) NO: K162864(Traditional) ATTN: Alicia Hemphill PHONE NO : 972 6774783 10201 Bubb Road SE DECISION MADE: 13-JAN-17 Cupertino CA 95014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Elite Expandable Interbody Fusion Device Spineology Inc. 510(k) NO: K162879(Traditional) ATTN: Jacqueline A. Hauge PHONE NO : 651 2568500 7800 3rd Street N., Suite 600 SE DECISION MADE: 30-JAN-17 St. Paul MN 55127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KARL STORZ ICG Imaging System KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K162882(Traditional) ATTN: SUSIE S. CHEN PHONE NO : 424 2188201 2151 E. GRAND AVENUE SE DECISION MADE: 26-JAN-17 EL SEGUNDO CA 90245 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SpineGuard DSG Zavation Screw System SPINEGUARD,S.A. 510(k) NO: K162884(Traditional) ATTN: Stephane Bette PHONE NO : 33 1 45184519 10 cours Louis Lumiere SE DECISION MADE: 12-JAN-17 Vincennes FR 94300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPY Phi Open Field Handheld Fluorescence Imaging System NOVADAQ TECHNOLOGIES INC. 510(k) NO: K162885(Traditional) ATTN: JEN PENDLEBURY PHONE NO : 905 6293822 205 8329 EASTLAKE DRIVE UNIT 101 SE DECISION MADE: 11-JAN-17 Burnaby CA V5A 4W2 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PrismaSATE Baxter Healthcare Corporation 510(k) NO: K162887(Special) ATTN: Kristen Bozzelli PHONE NO : 224 2703075 32650 North Wilson Road SE DECISION MADE: 06-JAN-17 Round Lake IL 60073 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 Roche Diagnostics 510(k) NO: K162895(Traditional) ATTN: Jane Phillips PHONE NO : 317 521 3338 9115 Hague Road SE DECISION MADE: 18-JAN-17 Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CSX-30 Flat Panel Detector Canon, Inc. – Medical Equipment Gr510(k) NO: K162909(Traditional) ATTN: Shinji Mori PHONE NO : 81 3 37582111 9-1, Imaikami-cho, Nakahara-ku SE DECISION MADE: 27-JAN-17 Kawasaki JP 211-8501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU) HARTALEGA SDB. BHD. 510(k) NO: K162924(Traditional) ATTN: KUAN KAM HON PHONE NO : 603 6 2771733 DATARAN SD PJU9 SE DECISION MADE: 24-JAN-17 BANDAR SRI DAMANSARA MY 52200 510(k) STATEMENT DEVICE: Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K162931(Abbreviated) ATTN: Ruojuan Zhang PHONE NO : 31 631 685825 VEENPLUIS 4-6 SE DECISION MADE: 06-JAN-17 BEST NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ranfac Fat Aspiration Cannula RANFAC CORP. 510(k) NO: K162932(Traditional) ATTN: CHRISTOPHER WHELAN PHONE NO : 508 5884400 30 DOHERTY AVENUE, P.O. BOX 635 SE DECISION MADE: 19-JAN-17 Avon MA 02322 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 8ch Knee-Foot SPEEDER QUALITY ELECTRODYNAMICS, LLC 510(k) NO: K162946(Traditional) ATTN: KATHLEEN ARAS PHONE NO : 440 4842964 700 BETA DRIVE SUITE 100 SE DECISION MADE: 06-JAN-17 MAYFIELD VILLAGE OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set DIASORIN INC. 510(k) NO: K162959(Special) ATTN: JOHN WALTER PHONE NO : 651 4399710 1951 NORTHWESTERN AVE. SE DECISION MADE: 04-JAN-17 STILLWATER MN 55082-0285 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set DIASORIN INC. 510(k) NO: K162961(Special) ATTN: JOHN WALTER PHONE NO : 651 4399710 1951 NORTHWESTERN AVE. SE DECISION MADE: 05-JAN-17 STILLWATER MN 55082-0285 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OrthAlign Plus System OrthAlign, Inc. 510(k) NO: K162962(Traditional) ATTN: David Vancelette PHONE NO : 949 7152424 120 Columbia, Suite 500 SE DECISION MADE: 23-JAN-17 Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set DiaSorin Inc. 510(k) NO: K162969(Special) ATTN: John Walter PHONE NO : 651 4399710 1951 Northwestern Avenue SE DECISION MADE: 06-JAN-17 Stillwater MN 55082-0285 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PreludeSYNC Radial Compression Device Merit Medical Systems, Inc. 510(k) NO: K162988(Traditional) ATTN: Ileana Davis PHONE NO : 801 208 4187 1600 West Merit Parkway SE DECISION MADE: 25-JAN-17 South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Radifocus Glidewire Advantage Track Ashitaka Factory of Terumo Coporat510(k) NO: K163004(Traditional) ATTN: Dina Justice PHONE NO : 732 4124166 150 Maimaigi-cho SE DECISION MADE: 30-JAN-17 Fujinomiya Shizuoka JP 418-0015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) bioMerieux, Inc. 510(k) NO: K163006(Traditional) ATTN: Jennifer Jines PHONE NO : 314 7318352 595 Anglum Rd. SE DECISION MADE: 24-JAN-17 Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Quantib Brain 1.2 Quantib BV 510(k) NO: K163013(Special) ATTN: Rudolf Scholte PHONE NO : 31 108 4111749 Westblaak 106 SE DECISION MADE: 06-JAN-17 Rotterdam NL 3012KM 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AOS Small Bone Nailing System Advanced Orthopaedic Solutions, In510(k) NO: K163014(Traditional) ATTN: Alex Bhaskarla PHONE NO : 310 5339966 3203 Kashiwa St. SE DECISION MADE: 24-JAN-17 Torrance CA 90505 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak BIO-RAD LABORATORIES 510(k) NO: K163015(Traditional) ATTN: ELIZABETH PLATT PHONE NO : 949 5981285 9500 JERONIMO ROAD SE DECISION MADE: 10-JAN-17 IRVINE CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: chromID Strepto B agar bioMerieux, Inc. 510(k) NO: K163042(Traditional) ATTN: Karen Russell PHONE NO : 314 7318639 595 Anglum Road SE DECISION MADE: 27-JAN-17 Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOLOC® 3Di Ankle Fracture Plating System WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K163044(Traditional) ATTN: Val Myles PHONE NO : 901 2905162 1023 CHERRY RD SE DECISION MADE: 26-JAN-17 Memphis TN 38117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle BOSTON SCIENTIFIC 510(k) NO: K163058(Traditional) ATTN: Jennifer Edouard PHONE NO : 508 6836134 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 30-JAN-17 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM OLYMPUS MEDICAL SYSTEMS CORP. 510(k) NO: K163069(Traditional) ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694 2951 Ishikawa-cho SE DECISION MADE: 19-JAN-17 Hachioji JP 182-8507 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Lifestyles Zero Lubricated Latex Male Condom ANSELL HEALTHCARE PRODUCTS, LLC 510(k) NO: K163107(Abbreviated) ATTN: Robert Mahler PHONE NO : 732 3452174 111 Wood Avenue South, Suite 210 SE DECISION MADE: 23-JAN-17 Iselin NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series GRANDWAY TECHNOLOGY (SHENZHEN) LIM510(k) NO: K163113(Special) ATTN: Patrick Chow PHONE NO : 852 28516789 BLOCK 7, ZHU KENG INDUSTRIAL ZONE,SE DECISION MADE: 19-JAN-17 SHENZHEN CN 518118 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sapphire II PRO OrbusNeich Medical Inc. 510(k) NO: K163114(Traditional) ATTN: John Pazienza PHONE NO : 954 7300711 5363 NW 35th Avenue SE DECISION MADE: 05-JAN-17 Fort Lauderdale FL 33309 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 Philips Medical Systems Nederland 510(k) NO: K163116(Abbreviated) ATTN: Ruojuan Zhang PHONE NO : 31 63 1685825 Veenpluis 4-6 SE DECISION MADE: 06-JAN-17 Best NL 5684PC 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System Philips Ultrasound, Inc. 510(k) NO: K163120(Traditional) ATTN: Peng Cui PHONE NO : 978 6597966 3000 Minuteman Road SE DECISION MADE: 10-JAN-17 Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NobelClinician, DTX Studio implant NOBEL BIOCARE AB 510(k) NO: K163122(Traditional) ATTN: CHALEMAGNE CHUA PHONE NO : 714 2824800 7830 VASTRA HAMNGATAN 1 SE DECISION MADE: 31-JAN-17 Goteborg SE SE-411 17 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Epic Pro Biolase, Inc 510(k) NO: K163128(Special) ATTN: Alicia Mszyca PHONE NO : 949 2268471 4 Cromwell SE DECISION MADE: 11-JAN-17 Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAMIC ClearaCIL Contrast Injection Lines AngioDynamics, Inc. 510(k) NO: K163141(Traditional) ATTN: Teri Juckett PHONE NO : 518 7951142 10 Glens Falls Technology Park SE DECISION MADE: 06-JAN-17 Glens Falls NY 12801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader ArthroCare Corporation 510(k) NO: K163142(Special) ATTN: Laura Kasperowicz PHONE NO : 949 5852406 15285 Alton Parkway Suite 200 SE DECISION MADE: 06-JAN-17 Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides Materialise NV 510(k) NO: K163156(Traditional) ATTN: Oliver Clemens PHONE NO : 32 16 396280 Technologielaan 15 SE DECISION MADE: 18-JAN-17 Leuven BE 3001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352 CAPILLUS, LLC 510(k) NO: K163170(Traditional) ATTN: PATRICIA SCHNOOR PHONE NO : 786 8881874 1715 NW 82nd Avenue SE DECISION MADE: 31-JAN-17 MIAMI FL 33126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Exilis XP II BTL Industries, Inc. 510(k) NO: K163176(Traditional) ATTN: David Chmel PHONE NO : 866 2851656 47 Loring Drive SE DECISION MADE: 12-JAN-17 Framingham MA 01702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Onli Intermittent Catheter HOLLISTER INCORPORATED 510(k) NO: K163179(Special) ATTN: JEANNE LEE PHONE NO : 847 99663540 2000 HOLLISTER DRIVE SE DECISION MADE: 26-JAN-17 LIBERTYVILLE IL 60048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 48CH Head Coil GE Healthcare Coils (USA Instrumen510(k) NO: K163205(Traditional) ATTN: Mary A. Mayka PHONE NO : 330 9955708 1515 Danner Drive SE DECISION MADE: 12-JAN-17 Aurora OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Philips CombiDiagnost R90 Philips Medical Systems DMC GmbH 510(k) NO: K163210(Traditional) ATTN: Ming Xiao PHONE NO : 49 40 50782306 Roentgenstrasse 24-26 SE DECISION MADE: 31-JAN-17 Hamburg DE 22335 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGNETOM Sempra with syngo MR E11S Siemens Medical Solutions USA, Inc510(k) NO: K163211(Traditional) ATTN: Cordell L Fields PHONE NO : 610 4486469 65 Valley Steam Pkwy. SE DECISION MADE: 27-JAN-17 Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Chameleon PTA Balloon Catheter AV Medical Technologies Ltd 510(k) NO: K163231(Traditional) ATTN: Limor Sandach PHONE NO : 972 77 5055645 21b Habarzel Street SE DECISION MADE: 17-JAN-17 Tel-Aviv IL 6971029 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Mammomat Fusion with Stereotactic Biopsy SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K163252(Traditional) ATTN: Denise Adams PHONE NO : 610 4486139 40 Liberty Boulevard, Mail Code 65SE DECISION MADE: 10-JAN-17 Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Arterys Cardio DL ARTERYS INC. 510(k) NO: K163253(Traditional) ATTN: Golnaz Moeini PHONE NO : 408 5043187 51 FEDERAL ST. SUITE 305 SE DECISION MADE: 05-JAN-17 SAN FRANCISCO CA 94107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens Acuity Polymers, Inc. 510(k) NO: K163254(Traditional) ATTN: James A Bonafini PHONE NO : 585 458 8409 1667 Lake Avenue, Suite 354 SE DECISION MADE: 18-JAN-17 Rochester NY 14615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CrossFT Knotless Suture Anchor with Disposable Driver ConMed Corporation 510(k) NO: K163258(Special) ATTN: Nyrobia Freeman PHONE NO : 727 3995416 525 French Road SE DECISION MADE: 25-JAN-17 Utica NY 13502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RP Lite 760R Mego Afek AC Ltd. 510(k) NO: K163280(Special) ATTN: Ilan Sharon PHONE NO : 972 77 9084276 Kibbutz Afek SE DECISION MADE: 27-JAN-17 Kibbutz Afek IL 3004200 510(k) STATEMENT DEVICE: FastStroke GEf Medical Systems SCS 510(k) NO: K163281(Traditional) ATTN: Kristine Schraufnagel PHONE NO : 262 3127344 283 rue de la Miniere SE DECISION MADE: 26-JAN-17 Buc FR 78530 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NovaBone IRM NovaBone Products, LLC 510(k) NO: K163310(Traditional) ATTN: Gregory Pomrink PHONE NO : 386 4621010 13510 NW US Highway 441 SE DECISION MADE: 18-JAN-17 Alachua FL 32615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software Siemens Medical Solutions USA, Inc510(k) NO: K163312(Traditional) ATTN: Cordell L Fields PHONE NO : 610 4486469 40 Liberty Boulevard Mail Code 65-SE DECISION MADE: 27-JAN-17 Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: nordicBrainEx NordicNeurolab AS 510(k) NO: K163324(Traditional) ATTN: CHANDANA GURUNG BHANDARI PHONE NO : 47 557 07095 MOLLENDALSVEIEN 65C SE DECISION MADE: 27-JAN-17 BERGEN NO N-5009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FITBONE TAA WITTENSTEIN intens GmbH 510(k) NO: K163368(Traditional) ATTN: Hartmut Kampa PHONE NO : 49 7931 49310485 Walter-Wittensstein-StraBe 1 SE DECISION MADE: 26-JAN-17 Igersheim DE 97999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUSON P500 Ultrasound System Siemens Medical Solutions USA, Inc510(k) NO: K163396(Third Party - Traditional) ATTN: Shelly Pearce PHONE NO : 650 2790134 685 East Middlefield Road SE DECISION MADE: 04-JAN-17 Moutain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Isolator Multifunctional Linear Pen AtriCure Inc. 510(k) NO: K163408(Special) ATTN: Melissa Smallwood PHONE NO : 513 6444736 7555 Innovation Way SE DECISION MADE: 03-JAN-17 Mason OH 45040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DigitalDiagnost C50 PHILIPS HEALTHCARE (SUZHOU) CO., L510(k) NO: K163410(Special) ATTN: ALINA ZHOU PHONE NO : 86 512 67336582 NO. 258, ZHONG YUAN ROAD SUZHOU INSE DECISION MADE: 04-JAN-17 SUZHOU CN 215024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: syngo.via MI Workflows Siemens Medical Solutions USA, Inc510(k) NO: K163421(Special) ATTN: Veronica Padharia PHONE NO : 630 8775761 810 Innovation Drive SE DECISION MADE: 03-JAN-17 Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON United State Endoscopy Group, Inc.510(k) NO: K163424(Special) ATTN: Ganga Kolli PHONE NO : 440 3586261 5976 Heisley Rd. SE DECISION MADE: 04-JAN-17 Mentor OH 44060 510(k) STATEMENT DEVICE: X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System SONOSCAPE MEDICAL CORP. 510(k) NO: K163427(Special) ATTN: Toki Wu PHONE NO : 86 755 26722890 4/f, 5/f, 8/f, 9/f & 10/f, yizhe bSE DECISION MADE: 03-JAN-17 Shenzhen CN 518051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: B6 Beijing East Whale Imaging Technol510(k) NO: K163429(Traditional) ATTN: Sharon Fan PHONE NO : 86 10 67892701 8058 Unit701, Building1, Yongchang InduSE DECISION MADE: 04-JAN-17 Beijing CH 100176 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Spectre guidewire Vascular Solutions, Inc. 510(k) NO: K163444(Special) ATTN: Beka Vite PHONE NO : 763 6575732 6464 Sycamore Court North SE DECISION MADE: 06-JAN-17 Minneapolis MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm ETHICON ENDO-SURGERY, LLC 510(k) NO: K163454(Special) ATTN: Carmen Ortiz PHONE NO : 787 2726500 6144 475 CALLE C SE DECISION MADE: 05-JAN-17 Guaynabo PR 00969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DuraGen Secure Dural Regeneration Matrix INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K163456(Special) ATTN: YARA HAMID PHONE NO : 609 9366858 311 ENTERPRISE DRIVE SE DECISION MADE: 06-JAN-17 PLAINSBORO NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NeuraGen 3D Nerve Guide Matrix Integra LifeSciences Corporation 510(k) NO: K163457(Special) ATTN: Gabriella Green PHONE NO : 609 2162970 311 Enterprise Drive SE DECISION MADE: 06-JAN-17 PLAINSBORO NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: R2P Metacross RX KANEKA CORPORATION 510(k) NO: K163479(Special) ATTN: TOSHIHIKO MOTOMINE PHONE NO : 81 355 748023 1-12-32, AKASAKA, MINATO-KU SE DECISION MADE: 11-JAN-17 TOKYO JP 107-6028 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: StatStrip Xpress 2 Glucose Hospital Meter System Nova Biomedical Corporation 510(k) NO: K163490(Special) ATTN: Paul W. MacDonald PHONE NO : 781 6473700 200 Prospect Street SE DECISION MADE: 06-JAN-17 Waltham MA 02454 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear United states Endoscopy Group, Inc510(k) NO: K163492(Special) ATTN: Carroll Martin PHONE NO : 440 3586259 5976 Heisley Road SE DECISION MADE: 06-JAN-17 Mentor OH 44060 510(k) STATEMENT DEVICE: RX DC CEFLA SC 510(k) NO: K163519(Traditional) ATTN: BORTOLOTTI LORENZO PHONE NO : 39 054 2653441 VIA SELICE PROV. LE 23/A SE DECISION MADE: 13-JAN-17 IMOLA IT 40026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Lumipulse G LH Calibrators FUJIREBIO DIAGNOSTICS, INC 510(k) NO: K163521(Abbreviated) ATTN: DIANA DICKSON PHONE NO : 610 2403917 201 GREAT VALLEY PARKWAY SE DECISION MADE: 12-JAN-17 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EzDent-i; E2; ProraView EWOO SOFT CO., LTD. 510(k) NO: K163533(Special) ATTN: YOUNG SEOK KIM PHONE NO : 82 318 0156171 801-HO, VATECHNETWORKS BLDG 13, SASE DECISION MADE: 12-JAN-17 HWASEONG-SI KR 18449 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Lumipulse G FSH-N Calibrators Fujirebio Diagnostics, Inc. 510(k) NO: K163534(Abbreviated) ATTN: Diana Dickerson PHONE NO : 610 2403917 201 Great Valley Parkway SE DECISION MADE: 13-JAN-17 Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Magseed Magnetic Marker System ENDOMAGNETICS LTD 510(k) NO: K163541(Special) ATTN: ANDREW SHAWCROSS PHONE NO : 44 012 230652540 THE JEFFREYS BUILDING COWLEY ROAD SE DECISION MADE: 13-JAN-17 CAMBRIDGE GB CB4 0WS 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case Datascope Corp. 510(k) NO: K163542(Special) ATTN: Helder A. Sousa PHONE NO : 973 7097465 1300 MacArthur Blvd. SE DECISION MADE: 31-JAN-17 Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Lumipulse G Prolactin FUJIREBIO DIAGNOSTICS, INC. 510(k) NO: K163544(Abbreviated) ATTN: STACEY DOLAN PHONE NO : 610 2403843 201 GREAT VALLEY PARKWAY SE DECISION MADE: 12-JAN-17 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Lumipulse G Progesterone-N Calibrators Fujirebio Diagnostics, Inc. 510(k) NO: K163546(Abbreviated) ATTN: Stacey Dolan PHONE NO : 610 2403843 201 Great Valley Parkway SE DECISION MADE: 13-JAN-17 Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test Immunostics, Inc. 510(k) NO: K163554(Special) ATTN: Antoinette Prusik PHONE NO : 732 9180770 1750 Brielle Ave., AS SE DECISION MADE: 17-JAN-17 Ocean NJ 07712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Multi Modality Viewer Vital Images, Inc. 510(k) NO: K163574(Traditional) ATTN: Susan Atwood PHONE NO : 952 4879759 5850 Opus Parkway Suite 300 SE DECISION MADE: 26-JAN-17 Minnetonka ME 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEDEX WL070+ DENTMATE TECHNOLOGY CO., LTD. 510(k) NO: K163605(Special) ATTN: CHENG-FENG CHOU PHONE NO : 886 2 89769226 8F, No.8-11, Sec.1, Zhongxing RoadSE DECISION MADE: 19-JAN-17 New Taipei TW 24872 510(k) STATEMENT DEVICE: Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves Covidien 510(k) NO: K163620(Special) ATTN: Nicole Genco PHONE NO : 508 4524128 15 Hampshire Stree SE DECISION MADE: 19-JAN-17 Mansfield MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems Siemens Medical Solutions USA, Inc510(k) NO: K163635(Third Party - Traditional) ATTN: Sulgue Choi PHONE NO : 425 2819898 685 East Middlefield Road SE DECISION MADE: 12-JAN-17 Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Quantum Workstation Spectrum Medical Ltd 510(k) NO: K163657(Special) ATTN: Mark Drain PHONE NO : 440 1242 650120 Harrier 4, Meteor Business Park, CSE DECISION MADE: 18-JAN-17 Gloucester GB GL2 9QL 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pantera LEO BIOTRONIK, INC. 510(k) NO: K163660(Special) ATTN: Jon Brumbaugh PHONE NO : 888 3450374 6024 JEAN ROAD SE DECISION MADE: 26-JAN-17 LAKE OSWEGO OR 97035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3M Clear Tray Aligner 3M Unitek Corporation 510(k) NO: K163689(Third Party - Traditional) ATTN: Yanine Garcia-Quezada PHONE NO : 651 7368238 2724 South Peck Road SE DECISION MADE: 27-JAN-17 Monrovia CA 91016 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: IntraClude Intra-Aortic Occlusion Device Edwards Lifesciences LLC 510(k) NO: K163693(Special) ATTN: Lisa G. Hessabi PHONE NO : 949 2506384 One Edwards Way SE DECISION MADE: 26-JAN-17 Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EzRay Air W Vatech Co., Ltd 510(k) NO: K163705(Special) ATTN: Daniel Kim PHONE NO : 82 31 3799492 13, Samsung 1-ro 2-gil SE DECISION MADE: 24-JAN-17 Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Allura Xper R9 PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K163715(Special) ATTN: JEANETTE BECKER PHONE NO : 31 611 386380 VEENPLUIS 4-6 SE DECISION MADE: 26-JAN-17 BEST NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: nvc Nvision Biomedical Technologies, L510(k) NO: K170074(Special) ATTN: Diana L Langham PHONE NO : 210 5453713 1350 N Loop 1604 E, Suite 103 SE DECISION MADE: 24-JAN-17 San Antonio TX 78232 510(k) SUMMARY AVAILABLE FROM FDA
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