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

Company510(k)sRecalls
Arthrex, Inc.190
Teleflex Medical98
Smith & Nephew, Inc.111
Riverpoint Medical70
Covidien, LLC14
Medos International SARL50
Threadstone, LLC50
Anulex Technologies, Inc.40
Musculoskeletal Transplant Foundation31
Sentreheart40
Decided510(k)Device and applicantCode
Jan 6, 2017K163142SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedSt
ArthroCare Corporation
GAT
Dec 19, 2016K160854MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture
Biomet Manafacturing Corp.
GAT
Dec 15, 2016K162247PERMATAPE
Medos International SARL, CH
GAT
Nov 10, 2016K162310XBraid TT Suture Tape
Stryker
GAT
Nov 7, 2016K161638SPEEDTRAP Graft Preparation System
Medos International SARL, CH
GAT
Aug 12, 2016K153089'cottony' II TAPE, PLEDGETS
Teleflexmedical, Inc.
GAT
Jul 14, 2016K153087IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved
Ivy Sports Medicine, LLC
GAT
Jun 16, 2016K153076silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEE
Teleflexmedical, Inc.
GAT
Mar 3, 2016K153746Dunamis Force DFX Tensile Tape
Dunamis, LLC
GAT
Feb 12, 2016K153307HS SutureTape
Riverpoint Medical
GAT
Feb 8, 2016K152868ExpressBraid Graft Manipulation
Biomet Manufacturing Corp
GAT
Nov 25, 2015K153096LARIAT RS Suture Delivery Device
Sentreheart, Inc.
GAT
Oct 29, 2015K151758ALAR Nasal Valve Stent
Medtronic Xomed, Inc.
GAT
Aug 18, 2015K151009Nexus Suture
Baylis Medical Company, Inc., CA
GAT
Aug 13, 2015K150584Stryker Suture Tape
Stryker
GAT
Jul 21, 2015K143356NovoStitch Plus Meniscal Repair System
Ceterix Orthopaedics, Inc.
GAT
Jun 29, 2015K150327Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2
Dunamis, LLC
GAT
Apr 2, 2015K150438Force Fiber OrthoTape suture
Teleflexmedical, Inc.
GAT
Sep 12, 2014K142241LARIAT sulture Delivery Device
Sentreheart, Inc.
GAT
Jun 23, 2014K141072SUPOLENE
Resorba Medical GmbH, DE
GAT
Jun 10, 2014K133770A.I.M. KNOTLESS MENISCAL REPAIR DEVICE
Anchor Innovation Medical (A.I.M.)
GAT
Jan 30, 2014K140019ARTHREX BIOSUTURE
Arthrex, Inc.
GAT
Dec 5, 2013K132079TFCC FAST-FIX KIT
Smith & Nephew, Inc.
GAT
Oct 30, 2013K132357SMITH & NEPHEW ULTRATAPE
Smith & Nephew, Inc.
GAT
Jul 31, 2013K132043ARTHREX SPEEDCINCH
Arthrex, Inc.
GAT
May 21, 2013K122735SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2
Sorin Group USA, Inc.
GAT
Nov 7, 2012K123268SMARTSTITCH PERFECTPASSER SYSTEM
Arthocare Corporation
GAT
Oct 18, 2012K121861SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N
Smith & Nephew, Inc.
GAT
Sep 25, 2012K122374ARTHREX SUTURE (UHMWPE)
Arthrex, Inc.
GAT
Jul 12, 2012K121306SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE
Arthocare Corporation
GAT
Jun 4, 2012K121413CROSSFIX II MEMISCAL REPAIR DEVICE
Cayenne Medical, Inc.
GAT
Apr 6, 2012K112899ARTHREX BIO-SUTURE
Arthrex, Inc.
GAT
Apr 8, 2011K101377SMITH & NEWPHEW ULTRABRAID II SUTURE
Smith & Newphew, Inc.
GAT
Nov 23, 2010K102339CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE
Conmed Linvatec
GAT
Nov 10, 2010K103052V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE
Covidien, LLC
GAT
Oct 20, 2010K102916G-CATH TISSUE ANCHOR DELIVERY CATHETER
Usgi Medical
GAT
Aug 4, 2010K102028NEOTRACT ANCHOR SYSTEM MODEL TAS400
Neotract, Inc.
GAT
Jul 15, 2010K101252NEOTRACT ANCHOR SYSTEM MODEL: REF 11208
Neotract, Inc.
GAT
May 10, 2010K100006HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED
Riverpoint Medical
GAT
Mar 18, 2010K094028CP-FIBER (ORTHOFIBER)
Cp Medical
GAT
Mar 17, 2010K100572VERSACLOSE, MODEL VC-200-01
Anulex Technologies, Inc.
GAT
Mar 10, 2010K100506FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK
Teleflex Medical
GAT
Feb 17, 2010K100251G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333
Usgi Medical
GAT
Jan 28, 2010K092508FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT,
Smith & Nephew, Inc.
GAT
Nov 13, 2009K091061IMPLICITGUIDE SURGICAL SUTURE SYSTEM
Implicitcare, LLC
GAT
Oct 9, 2009K091574SILK BLACK BRAIDED SURGICAL SUTURES, NYLON MONOFILAMENT BLUE AND BLACK SURGICAL SUTURES
Supplidores Unidos Internacionales, S.A.
GAT
Oct 7, 2009K093018G-PROX ENDOSCOPIC GRASPER, MODEL 205333
Usgi Medical
GAT
Sep 15, 2009K092533FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES
Beere Precision Medical Instruments, Kmedic, Telef
GAT
Jun 12, 2009K091432XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01
Anulex Technologies, Inc.
GAT
May 6, 2009K090385LARIAT II SUTURE DELIVERY DEVICE
Sentreheart, Inc.
GAT

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