ClearanceBrief
Panels › General, Plastic Surgery › Product code GAT · Class 2

Suture, Nonabsorbable, Synthetic, Polyethylene

Regulation 878.5000

5510(k)s in 12 months (176 all time)
0recalls in 12 months (23 all time)
21recalls that name a 510(k)
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Top companies in GAT

Decided510(k)Device and applicantCode
May 4, 2009K091016COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE
Surgical Devices, A Global Business Unit Covidien
GAT
Mar 19, 2009K090128TAC-TITE (TM)
Core Essence Orthopaedics, Inc.
GAT
Jan 16, 2009K082518DUAL NEEDLE SUTURE PASSER SYSTEM
Cayenne Medical, Inc.
GAT
Dec 1, 2008K082535COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE
Surgical Devices, A Global Business Unit Covidien
GAT
Feb 11, 2008K073149MENISCAL CINCH
Arthrex, Inc.
GAT
Feb 7, 2008K073096ANCHORAGE CLOSURE DEVICE
Epitek, Inc.
GAT
Feb 1, 2008K073651NEOTRACT ANCHOR SYSTEM
Neotract, Inc.
GAT
Oct 19, 2007K071796CAPSEW PLICATION SYSTEM
Cayenne Medical, Inc.
GAT
Sep 18, 2007K072322ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS
Smith & Nephew, Inc.
GAT
Jul 11, 2007K070253AXYA SUTURE WELDING SYSTEM AND KIT
Axya Medical, Inc.
GAT
Jul 3, 2007K071622ARTHREX FIBERWIRE
Arthrex, Inc.
GAT
Apr 2, 2007K070673FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE
Teleflexmedical, Inc.
GAT
Feb 9, 2007K063778FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE
Teleflex Medical
GAT
Dec 6, 2006K061276G-PROX ENDOSCOPIC GRASPER
Usgi Medical
GAT
Dec 4, 2006K063194TUFFLEX POLYESTER SUTURE
Axya Medical, Inc.
GAT
Oct 11, 2006K060163CARDIOFLON, CARDIOXYL
Peters Surgical, FR
GAT
Sep 1, 2006K062307XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS
Anulex Technologies, Inc.
GAT
Sep 1, 2006K060165AXYAFLEX POLYESTER SUTURE
Axya Medical, Inc.
GAT
Aug 9, 2006K060367TENOLIG
Fournitures Hospitalieres Industrie, FR
GAT
Jul 5, 2006K061386ANCHOR BAND SUTURING SYSTEM, MODEL SR-AB
Anulex Technologies, Inc.
GAT
Jun 2, 2006K060721LARIAT LOOP APPLICATOR
Sentreheart
GAT
Mar 16, 2006K053339ALLOFIX ANCHOR
Musculoskeletal Transplant Foundation
GAT
Dec 5, 2005K050150MANI NEEDLE & SUTURE PACK
Mani, Inc.
GAT
Oct 21, 2005K052652SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE
Smith & Nephew, Inc.
GAT
Jun 2, 2005K041512NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE
Sutures India Private Limited, IN
GAT
Dec 23, 2004K042038MTF ALLOGRAFT ANCHOR
Musculoskeletal Transplant Foundation
GAT
Dec 10, 2004K041553ARTHREX SUTURE GRAFTING KIT
Arthrex, Inc.
GAT
Dec 1, 2004K042286UNIESTER C
United Medical Industries Co. , Ltd., SA
GAT
Oct 19, 2004K042031OPUS SPEEDSTITCH SUTURE DEVICE
Opus Medical, Inc.
GAT
Sep 17, 2004K041894ORTHOFIBER
Cp Medical
GAT
Aug 5, 2004K041589ARTHREX FIBERWIRE WITH SILK
Arthrex, Inc.
GAT
Jun 7, 2004K041216SMITH & NEPHEW ULTRABRAID SUTURE
Smith & Nephew, Inc.
GAT
Jun 4, 2004K040789DURABRAID SUTURE
Smith & Nephew, Inc.
GAT
Mar 15, 2004K040472FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE
Teleflex Medical
GAT
Mar 1, 2004K040232LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999
Lsi Solutions
GAT
Feb 12, 2004K033718MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE
Arthrotek, Inc.
GAT
Jan 15, 2004K033654FORCE FIBER
Teleflex Medical
GAT
Jan 14, 2004K032245ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239
Arthrex, Inc.
GAT
Dec 2, 2003K032901STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM
Stryker Endoscopy
GAT
Jun 18, 2003K023030DEMETECH POLYESTER NONABSORBABLE SUTURE
Demetech Corp.
GAT
Nov 7, 2002K021434ARTHREX FIBERWIRE IN USP SIZES
Arthrex, Inc.
GAT
Aug 20, 2002K022410SAPH-LOOP LIGATING LOOP
Genzyme Biosurgery
GAT
Jun 18, 2002K021019COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE
Genzyme Corp.
GAT
May 20, 2002K020902SERRALESTER
Serral, S.A. DE C.V.
GAT
Feb 27, 2002K013990LIFESTITCH SUTURING DEVICE
Edwards Lifesciences, LLC
GAT
Oct 4, 2001K012923ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201
Arthrex, Inc.
GAT
Sep 19, 2001K012201PREMICRON NONABSORBABLE PET SURGICAL SUTURE
Aesculap, Inc.
GAT
Aug 28, 2001K002172POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS)
Xiros Plc, GB
GAT
May 14, 2001K010673ARTHREX FIBERWIRE, MODEL SPU-02NB-3800
Arthrex, Inc.
GAT
Mar 5, 2001K003590GRAMS POLYESTER NONABSORBABLE SUTURE
Gramsmed, LLC
GAT

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