FDA 510(k) Applications for Medical Device Product Code "GAT"
(Suture, Nonabsorbable, Synthetic, Polyethylene)

FDA 510(k) Number Applicant Device Name Decision Date
K952535 ACUFEX MICROSURGICAL, INC. ACUFEX ENDOBUTTON TAPE 02/08/1996
K012201 AESCULAP, INC. PREMICRON NONABSORBABLE PET SURGICAL SUTURE 09/19/2001
K990088 AESCULAP, INC. SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE 02/10/1999
K170957 AlloSource ReConnex Pre-Sutured Tendon 03/20/2018
K133770 ANCHOR INNOVATION MEDICAL (A.I.M.) A.I.M. KNOTLESS MENISCAL REPAIR DEVICE 06/10/2014
K061386 ANULEX TECHNOLOGIES, INC ANCHOR BAND SUTURING SYSTEM, MODEL SR-AB 07/05/2006
K100572 ANULEX TECHNOLOGIES, INC VERSACLOSE, MODEL VC-200-01 03/17/2010
K062307 ANULEX TECHNOLOGIES, INC XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS 09/01/2006
K091432 ANULEX TECHNOLOGIES, INC XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01 06/12/2009
K000540 ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. POLYESTER NONABSORBABLE SURGICAL SUTURES, USP 04/27/2000
K180191 Arcuro Medical Ltd. SuperBall Meniscal Repair System 06/05/2018
K121306 ARTHOCARE CORPORATION SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE 07/12/2012
K123268 ARTHOCARE CORPORATION SMARTSTITCH PERFECTPASSER SYSTEM 11/07/2012
K112899 ARTHREX, INC. ARTHREX BIO-SUTURE 04/06/2012
K140019 ARTHREX, INC. ARTHREX BIOSUTURE 01/30/2014
K032245 ARTHREX, INC. ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239 01/14/2004
K071622 ARTHREX, INC. ARTHREX FIBERWIRE 07/03/2007
K021434 ARTHREX, INC. ARTHREX FIBERWIRE IN USP SIZES 11/07/2002
K041589 ARTHREX, INC. ARTHREX FIBERWIRE WITH SILK 08/05/2004
K010673 ARTHREX, INC. ARTHREX FIBERWIRE, MODEL SPU-02NB-3800 05/14/2001
K012923 ARTHREX, INC. ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201 10/04/2001
K132043 ARTHREX, INC. ARTHREX SPEEDCINCH 07/31/2013
K122374 ARTHREX, INC. ARTHREX SUTURE (UHMWPE) 09/25/2012
K041553 ARTHREX, INC. ARTHREX SUTURE GRAFTING KIT 12/10/2004
K073149 ARTHREX, INC. MENISCAL CINCH 02/11/2008
K171296 Arthrex, Inc. SutureTape 05/26/2017
K163142 ArthroCare Corporation SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader 01/06/2017
K033718 ARTHROTEK, INC. MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE 02/12/2004
K070253 AXYA MEDICAL, INC. AXYA SUTURE WELDING SYSTEM AND KIT 07/11/2007
K060165 AXYA MEDICAL, INC. AXYAFLEX POLYESTER SUTURE 09/01/2006
K063194 AXYA MEDICAL, INC. TUFFLEX POLYESTER SUTURE 12/04/2006
K151009 BAYLIS MEDICAL COMPANY INC. Nexus Suture 08/18/2015
K092533 BEERE PRECISION MEDICAL INSTRUMENTS, KMEDIC, TELEF FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES 09/15/2009
K160854 Biomet Manafacturing Corp. MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture 12/19/2016
K163651 Biomet Manufacturing Corp. ExpressBraid Graft Manipulation 02/17/2017
K152868 BIOMET MANUFACTURING CORP. ExpressBraid Graft Manipulation 02/08/2016
K071796 CAYENNE MEDICAL, INC. CAPSEW PLICATION SYSTEM 10/19/2007
K121413 CAYENNE MEDICAL, INC. CROSSFIX II MEMISCAL REPAIR DEVICE 06/04/2012
K082518 CAYENNE MEDICAL, INC. DUAL NEEDLE SUTURE PASSER SYSTEM 01/16/2009
K143356 Ceterix Orthopaedics, Inc. NovoStitch Plus Meniscal Repair System 07/21/2015
K180531 Ceterix Orthopaedics, Inc. NovoStitch Pro Meniscal Repair System 03/29/2018
K181772 Ceterix Orthopaedics, Inc. NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) 08/01/2018
K102339 CONMED LINVATEC CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE 11/23/2010
K090128 CORE ESSENCE ORTHOPAEDICS, INC. TAC-TITE (TM) 03/19/2009
K103052 Covidien LLC V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE 11/10/2010
K094028 CP MEDICAL CP-FIBER (ORTHOFIBER) 03/18/2010
K041894 CP MEDICAL ORTHOFIBER 09/17/2004
K001172 CP MEDICAL POLYESTER NONABSORBABLE SURGICAL SUTURES URP 06/23/2000
K930590 DAVIS & GECK, INC. SILK SUTURES 12/17/1993
K930591 DAVIS & GECK, INC. TI-CRON AND DACRON SUTURES 12/17/1993
K023030 DEMETECH CORP. DEMETECH POLYESTER NONABSORBABLE SUTURE 06/18/2003
K150327 Dunamis LLC Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2 06/29/2015
K153746 Dunamis LLC Dunamis Force DFX Tensile Tape 03/03/2016
K013990 EDWARDS LIFESCIENCES, LLC. LIFESTITCH SUTURING DEVICE 02/27/2002
K073096 EPITEK, INC. ANCHORAGE CLOSURE DEVICE 02/07/2008
K060367 FOURNITURES HOSPITALIERES INDUSTRIE TENOLIG 08/09/2006
K022410 GENZYME BIOSURGERY SAPH-LOOP LIGATING LOOP 08/20/2002
K021019 GENZYME CORP. COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE 06/18/2002
K001434 GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE 06/12/2000
K001440 GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) NEXTSTITCH CARDIOVASCULAR VALVE SUTURE 11/13/2000
K003590 GRAMSMED LLC GRAMS POLYESTER NONABSORBABLE SUTURE 03/05/2001
K091061 IMPLICITCARE, LLC IMPLICITGUIDE SURGICAL SUTURE SYSTEM 11/13/2009
K153087 Ivy Sports Medicine, LLC IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved 07/14/2016
K943949 LOOK, INC. POLYVIOLENE SURGICL SUTURE 11/10/1994
K926167 LOOK, INC. POLYVIOLENE SUTURE-REVISED LABELING 12/17/1993
K040232 LSI SOLUTIONS LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999 03/01/2004
K930945 LUKENS MEDICAL CORP. BRAIDED POLYESTER SURGICAL SUTURE 12/17/1993
K930942 LUKENS MEDICAL CORP. LUKENS SILK SURGICAL SUTURE 12/17/1993
K050150 MANI, INC. MANI NEEDLE & SUTURE PACK 12/05/2005
K961025 MEDICINE LODGE, INC. EXPANDED BODY SUTURE 04/15/1996
K181182 Medos International SARL DYNACORD Suture 08/02/2018
K162247 MEDOS INTERNATIONAL SARL PERMATAPE 12/15/2016
K161638 MEDOS INTERNATIONAL SARL SPEEDTRAP Graft Preparation System 11/07/2016
K920421 MEDSURG INDUSTRIES, INC. MEDSURG MARSHMALLOW TRAY 12/13/1993
K151758 MEDTRONIC XOMED INC. ALAR Nasal Valve Stent 10/29/2015
K053339 MUSCULOSKELETAL TRANSPLANT FOUNDATION ALLOFIX ANCHOR 03/16/2006
K042038 MUSCULOSKELETAL TRANSPLANT FOUNDATION MTF ALLOGRAFT ANCHOR 12/23/2004
K073651 NEOTRACT, INC. NEOTRACT ANCHOR SYSTEM 02/01/2008
K102028 NEOTRACT, INC. NEOTRACT ANCHOR SYSTEM MODEL TAS400 08/04/2010
K101252 NEOTRACT, INC. NEOTRACT ANCHOR SYSTEM MODEL: REF 11208 07/15/2010
K042031 OPUS MEDICAL, INC. OPUS SPEEDSTITCH SUTURE DEVICE 10/19/2004
K060163 PETERS SURGICAL CARDIOFLON, CARDIOXYL 10/11/2006
K961925 R.K. MEDICAL, L.L.C. POLYESTER NONABSORBABLE SURGICAL SUTURES USP 07/29/1996
K141072 RESORBA MEDICAL GMBH SUPOLENE 06/23/2014
K100006 RIVERPOINT MEDICAL HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED 05/10/2010
K153307 RIVERPOINT MEDICAL HS SutureTape 02/12/2016
K060721 SENTREHEART LARIAT LOOP APPLICATOR 06/02/2006
K090385 SENTREHEART INC. LARIAT II SUTURE DELIVERY DEVICE 05/06/2009
K142241 SENTREHEART INC. LARIAT sulture Delivery Device 09/12/2014
K153096 SentreHEART, Inc. LARIAT RS Suture Delivery Device 11/25/2015
K020902 SERRAL, S.A. DE C.V. SERRALESTER 05/20/2002
K970416 SMITH & NEPHEW ENDOSCOPY, INC. ACUFEX DOUBLE ARMED SUTURE NEEDLE 04/21/1997
K040789 SMITH & NEPHEW, INC. DURABRAID SUTURE 06/04/2004
K980155 SMITH & NEPHEW, INC. ENDOBUTTON CONTINUOUS LOOP 04/01/1998
K092508 SMITH & NEPHEW, INC. FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT, 01/28/2010
K984550 SMITH & NEPHEW, INC. PRE-THREADED ENDOBUTTON 03/01/1999
K052652 SMITH & NEPHEW, INC. SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE 10/21/2005
K121861 SMITH & NEPHEW, INC. SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N 10/18/2012
K041216 SMITH & NEPHEW, INC. SMITH & NEPHEW ULTRABRAID SUTURE 06/07/2004
K132357 SMITH & NEPHEW, INC. SMITH & NEPHEW ULTRATAPE 10/30/2013
K132079 SMITH & NEPHEW, INC. TFCC FAST-FIX KIT 12/05/2013
K072322 SMITH & NEPHEW, INC. ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS 09/18/2007
K101377 SMITH & NEWPHEW, INC SMITH & NEWPHEW ULTRABRAID II SUTURE 04/08/2011
K122735 SORIN GROUP USA INC. SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2 05/21/2013
K150584 Stryker Stryker Suture Tape 08/13/2015
K162310 Stryker XBraid TT Suture Tape 11/10/2016
K032901 Stryker Endoscopy STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM 12/02/2003
K091574 SUPPLIDORES UNIDOS INTERNACIONALES, S.A. SILK BLACK BRAIDED SURGICAL SUTURES, NYLON MONOFILAMENT BLUE AND BLACK SURGICAL SUTURES 10/09/2009
K082535 SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE 12/01/2008
K091016 SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE 05/04/2009
K932038 SURGICAL SPECIALTIES, INC. SUTURE NONABSORBABLE- SILK, POLYESTER 01/07/1994
K931916 SURGIMETRICS INTERNATIONAL, LTD. SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER 03/03/1994
K041512 SUTURES INDIA PRIVATE LIMITED NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE 06/02/2005
K943221 SUTURES LTD. SURGIBOND 12/05/1994
K943220 SUTURES LTD. SUTULENE 12/05/1994
K033654 TELEFLEX MEDICAL FORCE FIBER 01/15/2004
K040472 TELEFLEX MEDICAL FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE 03/15/2004
K100506 TELEFLEX MEDICAL FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK 03/10/2010
K063778 TELEFLEX MEDICAL FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE 02/09/2007
K172016 Teleflex Medical Incorporated Force Fiber Fusion Suture 10/03/2017
K181774 Teleflex Medical Incorporated Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture 10/10/2018
K153089 Teleflex Medical, Inc. 'cottony' II TAPE, PLEDGETS 08/12/2016
K070673 Teleflex Medical, Inc. FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE 04/02/2007
K150438 TELEFLEX MEDICAL, INC. Force Fiber OrthoTape suture 04/02/2015
K153076 Teleflex Medical, Inc. silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL 06/16/2016
K994000 TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. POLYESTER 02/04/2000
K042286 UNITED MEDICAL INDUSTRIES CO. LTD. UNIESTER C 12/01/2004
K972911 UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER 04/25/1998
K990952 UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES 04/01/1999
K955747 UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC USSC NONABSORBABLE SUTURES 02/27/1996
K102916 USGI MEDICAL G-CATH TISSUE ANCHOR DELIVERY CATHETER 10/20/2010
K100251 USGI MEDICAL G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333 02/17/2010
K061276 USGI MEDICAL G-PROX ENDOSCOPIC GRASPER 12/06/2006
K093018 USGI MEDICAL G-PROX ENDOSCOPIC GRASPER, MODEL 205333 10/07/2009
K170642 Wright Medical Technology, Inc. GRAVITYÖ Soft Tissue Repair System 08/22/2017
K171680 Xiros Ltd Infinity-Lock 3, Infinity-Lock 5 06/30/2017
K002172 XIROS PLC POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS) 08/28/2001


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