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 |
| K213046 | AlloSource | AceConnex Pre-Sutured Fascia | 06/27/2023 |
| 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 |
| K223500 | Arcuro Medical Ltd. | SuperBall Meniscal Repair System | 08/10/2023 |
| 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 |
| K220880 | Arthrex Inc. | Arthrex BioSuture | 10/27/2022 |
| K190707 | Arthrex Inc. | Arthrex SoftStitch | 10/02/2020 |
| K193575 | Arthrex Inc. | Arthrex SutureTape | 07/24/2020 |
| K221354 | Arthrex Inc. | Arthrex SutureTape | 09/09/2022 |
| K222078 | Arthrex, Inc | Arthrex SoftStitch | 09/14/2022 |
| 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 |
| K212146 | Arthrex, Inc. | Arthrex LoopLoc Knotless Suture | 10/25/2021 |
| 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 |
| K220186 | CONMED Corporation | Zone Specific AIM | 05/13/2022 |
| 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 |
| K230510 | Cynosure, LLC | MyEllevate | 07/06/2023 |
| K023030 | DEMETECH CORP. | DEMETECH POLYESTER NONABSORBABLE SUTURE | 06/18/2003 |
| K190777 | DemeTECH Corporation | DemeTECH DemeFORCE Nonabsorbable Surgical Suture | 07/31/2019 |
| 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 |
| K223822 | Embody, Inc. | ACTIVBRAIDÖ | 06/02/2023 |
| 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 |
| K040232 | LSI SOLUTIONS | LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999 | 03/01/2004 |
| 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 |
| K203186 | Medos International SARL | DYNATAPE Suture | 03/18/2021 |
| K220219 | Medos International SARL | PERMALOOP Suture, PERMATAPE Suture | 04/26/2022 |
| K162247 | MEDOS INTERNATIONAL SARL | PERMATAPE | 12/15/2016 |
| K161638 | MEDOS INTERNATIONAL SARL | SPEEDTRAP Graft Preparation System | 11/07/2016 |
| 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 |
| K181633 | Musculoskeletal Transplant Foundation | MTF Pre-Sutured Tendon | 03/15/2019 |
| 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 |
| K190817 | Riverpoint Medical | HS Fiber | 05/01/2019 |
| 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 |
| K202242 | Riverpoint Medical, LLC | HS Fiber | 09/10/2020 |
| K230036 | RTI Surgical, Inc | Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) | 06/23/2023 |
| K223122 | S.B.M. SAS (Science & Bio Materials) | MENIX«; MENIX« DUO | 08/03/2023 |
| 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 |
| K231183 | Shandong Haidike Medical Products Co.,Ltd. | Non absorbable Surgical Polyester Suture | 08/25/2023 |
| 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 |
| K203393 | Smith & Nephew, Inc. | FAST-FIX FLEX | 02/01/2021 |
| 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 |
| K041512 | SUTURES INDIA PRIVATE LIMITED | NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE | 06/02/2005 |
| 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 |
| K192490 | Teleflex Medical | Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch | 03/30/2020 |
| K172016 | Teleflex Medical Incorporated | Force Fiber Fusion Suture | 10/03/2017 |
| K191268 | Teleflex Medical Incorporated | Force Fiber Suture | 06/11/2019 |
| 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 |
| K210675 | Winter Innovations, Inc. | EasyWhip | 05/03/2021 |
| 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 |
| K192637 | Yunyi (Beijing) Medical Device Co., LTD | High Strength Suture | 03/02/2020 |
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