FDA releases March 2013 510(k) clearances

April 3, 2013 by Arezu Sarvestani

The Food & Drug Administration releases data on 510(k) clearances for medical devices it approved in March 2013.

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March 2013 510(k) Clearances

510(k) summaries or 510(k) statements for final decisions rendered during the period March 2013.
TOTAL 510(k)s THIS PERIOD   255                                    
TOTAL WITH SUMMARIES        243                                    
TOTAL WITH STATEMENTS        12

DEVICE: OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K123365(TRADITIONAL)
ATTN: SHERI L MUSGNUNG            PHONE NO : 484 896 3147  
3500 CORPORATE PARKWAY P.O. BOX 61SE DECISION MADE: 01-MAR-13
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNIGOLD GIARDIA
TRINITY BIOTECH                   510(k) NO: K120001(TRADITIONAL)
ATTN: LUPE  KAGAN                 PHONE NO : 760 929 0500  
5919 FARNSWORTH CT.               SE DECISION MADE: 01-MAR-13
CALIFORNIA CA 92008               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO
BAXTER HEALTHCARE CORP.           510(k) NO: K130245(SPECIAL)
ATTN: NANETTE  HEDDEN             PHONE NO : 224 270 3312  
32650 N WILSON RD.                SE DECISION MADE: 01-MAR-13
ROUND LAKE IL 60073 0490          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EVOLUTION BILIARY STENT SYSTEM
COOK IRELAND LTD                  510(k) NO: K121430(TRADITIONAL)
ATTN: JACINTA  KILMARTIN          PHONE NO : 353 613 34440
O HALLORAN ROAD NATIONAL TECHNOLOGSE DECISION MADE: 01-MAR-13
LIMERICK    IE 000                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS
DEPUY ORTHOPAEDICS                510(k) NO: K123924(TRADITIONAL)
ATTN: CORRENE  RAMY               PHONE NO : 574 371 4981  
700 ORTHOPAEDIC DRIVE             SE DECISION MADE: 01-MAR-13
WARSAW IN 46582                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDICVOD, MEDICAST, MEDISHOW, MEDISEARCH, CENTRAL STORAGE SYSTEM - CSS
ORPHEUS MEDICAL, LTD.             510(k) NO: K123426(TRADITIONAL)
ATTN: CLAY  ANSELMO               PHONE NO : 303 223 4303  
11925 WEST I-70 FRONTAGE RD. STE 9SE DECISION MADE: 01-MAR-13
WHEAT RIDGE CO 80033              510(k) SUMMARY AVAILABLE FROM FDA

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