Product Code: GAT
FDA class 2
21 CFR 878.5000
Suture, Nonabsorbable, Synthetic, Polyethylene
General, Plastic Surgery
The Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT) is a synthetic, nonabsorbable suture constructed from polyethylene, used in general and plastic surgery to provide lasting wound closure and tissue approximation where permanent suture material is indicated. It is classified as FDA Class 2, requiring a 510(k) premarket notification to demonstrate substantial equivalence. The device is regulated under 21 CFR 878.5000 in the General, Plastic Surgery specialty (SU). This device carries an implant designation, as it is placed through body tissue during application.
510(k)s
167
FEI Numbers
233
Registration Numbers
233
Unique Applicants
97
Years Active
31
Basic Information
- Product Code
- GAT
- Device Class
- FDA class 2
- Regulation Number
- 878.5000
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✓
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 167 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K242201 | HyperSuture White/Green Extension Line | Mar 27, 2025 | Substantially Equivalent | Threadstone LLC |
| K241376 | HyperSuture All Blue Extension Line | Aug 09, 2024 | Substantially Equivalent | Threadstone L.L.C. |
| K234079 | HyperSuture Extension Line | May 10, 2024 | Substantially Equivalent | Threadstone L.L.C. |
| K231163 | HS Fiber Sutures | Jan 05, 2024 | Substantially Equivalent | Riverpoint Medical |
| K230311 | HyperSuture | Nov 24, 2023 | Substantially Equivalent | Threadstone L.L.C. |
| K231183 | Non absorbable Surgical Polyester Suture | Aug 25, 2023 | Substantially Equivalent | Shandong Haidike Medical Products Co.,Ltd. |
| K223500 | SuperBall Meniscal Repair System | Aug 10, 2023 | Substantially Equivalent | Arcuro Medical Ltd. |
| K223122 | MENIX®; MENIX® DUO | Aug 03, 2023 | Substantially Equivalent | S.B.M. SAS (Science & Bio Materials) |
| K230510 | MyEllevate | Jul 06, 2023 | Substantially Equivalent | Cynosure, LLC |
| K213046 | AceConnex Pre-Sutured Fascia | Jun 27, 2023 | Substantially Equivalent | AlloSource |
| K230036 | Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) | Jun 23, 2023 | Substantially Equivalent | RTI Surgical, Inc |
| K223822 | ACTIVBRAID | Jun 02, 2023 | Substantially Equivalent | Embody, Inc. |
| K220880 | Arthrex BioSuture | Oct 27, 2022 | Substantially Equivalent | Arthrex Inc. |
| K222078 | Arthrex SoftStitch | Sep 14, 2022 | Substantially Equivalent | Arthrex, Inc |
| K221354 | Arthrex SutureTape | Sep 09, 2022 | Substantially Equivalent | Arthrex Inc. |
| K220186 | Zone Specific AIM | May 13, 2022 | Substantially Equivalent | CONMED Corporation |
| K220219 | PERMALOOP Suture, PERMATAPE Suture | Apr 26, 2022 | Substantially Equivalent | Medos International SARL |
| K212146 | Arthrex LoopLoc Knotless Suture | Oct 25, 2021 | Substantially Equivalent | Arthrex, Inc. |
| K210675 | EasyWhip | May 03, 2021 | Substantially Equivalent | Winter Innovations, Inc. |
| K203186 | DYNATAPE Suture | Mar 18, 2021 | Substantially Equivalent | Medos International SARL |
| K203393 | FAST-FIX FLEX | Feb 01, 2021 | Substantially Equivalent | Smith & Nephew, Inc. |
| K190707 | Arthrex SoftStitch | Oct 02, 2020 | Substantially Equivalent | Arthrex Inc. |
| K202242 | HS Fiber | Sep 10, 2020 | Substantially Equivalent | Riverpoint Medical, LLC |
| K193575 | Arthrex SutureTape | Jul 24, 2020 | Substantially Equivalent | Arthrex Inc. |
| K192490 | Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch | Mar 30, 2020 | Substantially Equivalent | Teleflex Medical |
| K192637 | High Strength Suture | Mar 02, 2020 | Substantially Equivalent | Yunyi (Beijing) Medical Device Co., LTD |
| K190777 | DemeTECH DemeFORCE Nonabsorbable Surgical Suture | Jul 31, 2019 | Substantially Equivalent | DemeTECH Corporation |
| K191268 | Force Fiber Suture | Jun 11, 2019 | Substantially Equivalent | Teleflex Medical Incorporated |
| K190817 | HS Fiber | May 01, 2019 | Substantially Equivalent | Riverpoint Medical |
| K181633 | MTF Pre-Sutured Tendon | Mar 15, 2019 | Substantially Equivalent | Musculoskeletal Transplant Foundation |
| K181774 | 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 | Oct 10, 2018 | Substantially Equivalent | Teleflex Medical Incorporated |
| K181182 | DYNACORD Suture | Aug 02, 2018 | Substantially Equivalent | Medos International SARL |
| K181772 | NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) | Aug 01, 2018 | Substantially Equivalent | Ceterix Orthopaedics, Inc. |
| K180191 | SuperBall Meniscal Repair System | Jun 05, 2018 | Substantially Equivalent | Arcuro Medical Ltd. |
| K180531 | NovoStitch Pro Meniscal Repair System | Mar 29, 2018 | Substantially Equivalent | Ceterix Orthopaedics, Inc. |
| K170957 | ReConnex Pre-Sutured Tendon | Mar 20, 2018 | Substantially Equivalent | AlloSource |
| K172016 | Force Fiber Fusion Suture | Oct 03, 2017 | Substantially Equivalent | Teleflex Medical Incorporated |
| K170642 | GRAVITY Soft Tissue Repair System | Aug 22, 2017 | Substantially Equivalent | Wright Medical Technology, Inc. |
| K171680 | Infinity-Lock 3, Infinity-Lock 5 | Jun 30, 2017 | Substantially Equivalent | Xiros Ltd |
| K171296 | SutureTape | May 26, 2017 | Substantially Equivalent | Arthrex, Inc. |
| K163651 | ExpressBraid Graft Manipulation | Feb 17, 2017 | Substantially Equivalent | Biomet Manufacturing Corp. |
| K163142 | SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader | Jan 06, 2017 | Substantially Equivalent | ArthroCare Corporation |
| K160854 | MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture | Dec 19, 2016 | Substantially Equivalent | Biomet Manafacturing Corp. |
| K162247 | PERMATAPE | Dec 15, 2016 | Substantially Equivalent | MEDOS INTERNATIONAL SARL |
| K162310 | XBraid TT Suture Tape | Nov 10, 2016 | Substantially Equivalent | Stryker |
| K161638 | SPEEDTRAP Graft Preparation System | Nov 07, 2016 | Substantially Equivalent | MEDOS INTERNATIONAL SARL |
| K153089 | 'cottony' II TAPE, PLEDGETS | Aug 12, 2016 | Substantially Equivalent | Teleflex Medical, Inc. |
| K153087 | IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved | Jul 14, 2016 | Substantially Equivalent | Ivy Sports Medicine, LLC |
| K153076 | silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL | Jun 16, 2016 | Substantially Equivalent | Teleflex Medical, Inc. |
| K153746 | Dunamis Force DFX Tensile Tape | Mar 03, 2016 | Substantially Equivalent | Dunamis LLC |
| K153307 | HS SutureTape | Feb 12, 2016 | Substantially Equivalent | RIVERPOINT MEDICAL |
| K152868 | ExpressBraid Graft Manipulation | Feb 08, 2016 | Substantially Equivalent | BIOMET MANUFACTURING CORP. |
| K153096 | LARIAT RS Suture Delivery Device | Nov 25, 2015 | Substantially Equivalent | SentreHEART, Inc. |
| K151758 | ALAR Nasal Valve Stent | Oct 29, 2015 | Substantially Equivalent | MEDTRONIC XOMED INC. |
| K151009 | Nexus Suture | Aug 18, 2015 | Substantially Equivalent | BAYLIS MEDICAL COMPANY INC. |
| K150584 | Stryker Suture Tape | Aug 13, 2015 | Substantially Equivalent | Stryker |
| K143356 | NovoStitch Plus Meniscal Repair System | Jul 21, 2015 | Substantially Equivalent | Ceterix Orthopaedics, Inc. |
| K150327 | Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2 | Jun 29, 2015 | Substantially Equivalent | Dunamis LLC |
| K150438 | Force Fiber OrthoTape suture | Apr 02, 2015 | Substantially Equivalent | TELEFLEX MEDICAL, INC. |
| K142241 | LARIAT sulture Delivery Device | Sep 12, 2014 | Substantially Equivalent | SENTREHEART INC. |
| K141072 | SUPOLENE | Jun 23, 2014 | Substantially Equivalent | RESORBA MEDICAL GMBH |
| K133770 | A.I.M. KNOTLESS MENISCAL REPAIR DEVICE | Jun 10, 2014 | Substantially Equivalent | ANCHOR INNOVATION MEDICAL (A.I.M.) |
| K140019 | ARTHREX BIOSUTURE | Jan 30, 2014 | Substantially Equivalent | ARTHREX, INC. |
| K132079 | TFCC FAST-FIX KIT | Dec 05, 2013 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K132357 | SMITH & NEPHEW ULTRATAPE | Oct 30, 2013 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K132043 | ARTHREX SPEEDCINCH | Jul 31, 2013 | Substantially Equivalent | ARTHREX, INC. |
| K122735 | SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2 | May 21, 2013 | Substantially Equivalent | SORIN GROUP USA INC. |
| K123268 | SMARTSTITCH PERFECTPASSER SYSTEM | Nov 07, 2012 | Substantially Equivalent | ARTHOCARE CORPORATION |
| K121861 | SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N | Oct 18, 2012 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K122374 | ARTHREX SUTURE (UHMWPE) | Sep 25, 2012 | Substantially Equivalent | ARTHREX, INC. |
| K121306 | SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE | Jul 12, 2012 | Substantially Equivalent | ARTHOCARE CORPORATION |
| K121413 | CROSSFIX II MEMISCAL REPAIR DEVICE | Jun 04, 2012 | Substantially Equivalent | CAYENNE MEDICAL, INC. |
| K112899 | ARTHREX BIO-SUTURE | Apr 06, 2012 | Substantially Equivalent | ARTHREX, INC. |
| K101377 | SMITH & NEWPHEW ULTRABRAID II SUTURE | Apr 08, 2011 | Substantially Equivalent | SMITH & NEWPHEW, INC |
| K102339 | CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE | Nov 23, 2010 | Substantially Equivalent | CONMED LINVATEC |
| K103052 | V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE | Nov 10, 2010 | Substantially Equivalent | Covidien LLC |
| K102916 | G-CATH TISSUE ANCHOR DELIVERY CATHETER | Oct 20, 2010 | Substantially Equivalent | USGI MEDICAL |
| K102028 | NEOTRACT ANCHOR SYSTEM MODEL TAS400 | Aug 04, 2010 | Substantially Equivalent | NEOTRACT, INC. |
| K101252 | NEOTRACT ANCHOR SYSTEM MODEL: REF 11208 | Jul 15, 2010 | Substantially Equivalent | NEOTRACT, INC. |
| K100006 | HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED | May 10, 2010 | Substantially Equivalent | RIVERPOINT MEDICAL |
| K094028 | CP-FIBER (ORTHOFIBER) | Mar 18, 2010 | Substantially Equivalent | CP MEDICAL |
| K100572 | VERSACLOSE, MODEL VC-200-01 | Mar 17, 2010 | Substantially Equivalent | ANULEX TECHNOLOGIES, INC |
| K100506 | FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK | Mar 10, 2010 | Substantially Equivalent | TELEFLEX MEDICAL |
| K100251 | G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333 | Feb 17, 2010 | Substantially Equivalent | USGI MEDICAL |
| K092508 | FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT, | Jan 28, 2010 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K091061 | IMPLICITGUIDE SURGICAL SUTURE SYSTEM | Nov 13, 2009 | Substantially Equivalent | IMPLICITCARE, LLC |
| K091574 | SILK BLACK BRAIDED SURGICAL SUTURES, NYLON MONOFILAMENT BLUE AND BLACK SURGICAL SUTURES | Oct 09, 2009 | Substantially Equivalent | SUPPLIDORES UNIDOS INTERNACIONALES, S.A. |
| K093018 | G-PROX ENDOSCOPIC GRASPER, MODEL 205333 | Oct 07, 2009 | Substantially Equivalent | USGI MEDICAL |
| K092533 | FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES | Sep 15, 2009 | Substantially Equivalent | BEERE PRECISION MEDICAL INSTRUMENTS, KMEDIC, TELEF |
| K091432 | XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01 | Jun 12, 2009 | Substantially Equivalent | ANULEX TECHNOLOGIES, INC |
| K090385 | LARIAT II SUTURE DELIVERY DEVICE | May 06, 2009 | Substantially Equivalent | SENTREHEART INC. |
| K091016 | COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE | May 04, 2009 | Substantially Equivalent | SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN |
| K090128 | TAC-TITE (TM) | Mar 19, 2009 | Substantially Equivalent | CORE ESSENCE ORTHOPAEDICS, INC. |
| K082518 | DUAL NEEDLE SUTURE PASSER SYSTEM | Jan 16, 2009 | Substantially Equivalent | CAYENNE MEDICAL, INC. |
| K082535 | COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE | Dec 01, 2008 | Substantially Equivalent | SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN |
| K073149 | MENISCAL CINCH | Feb 11, 2008 | Substantially Equivalent | ARTHREX, INC. |
| K073096 | ANCHORAGE CLOSURE DEVICE | Feb 07, 2008 | Substantially Equivalent | EPITEK, INC. |
| K073651 | NEOTRACT ANCHOR SYSTEM | Feb 01, 2008 | Substantially Equivalent | NEOTRACT, INC. |
| K071796 | CAPSEW PLICATION SYSTEM | Oct 19, 2007 | Substantially Equivalent | CAYENNE MEDICAL, INC. |
| K072322 | ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS | Sep 18, 2007 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K070253 | AXYA SUTURE WELDING SYSTEM AND KIT | Jul 11, 2007 | Substantially Equivalent | AXYA MEDICAL, INC. |
| K071622 | ARTHREX FIBERWIRE | Jul 03, 2007 | Substantially Equivalent | ARTHREX, INC. |
| K070673 | FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE | Apr 02, 2007 | Substantially Equivalent | Teleflex Medical, Inc. |
| K063778 | FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE | Feb 09, 2007 | Substantially Equivalent | TELEFLEX MEDICAL |
| K061276 | G-PROX ENDOSCOPIC GRASPER | Dec 06, 2006 | Substantially Equivalent | USGI MEDICAL |
| K063194 | TUFFLEX POLYESTER SUTURE | Dec 04, 2006 | Substantially Equivalent | AXYA MEDICAL, INC. |
| K060163 | CARDIOFLON, CARDIOXYL | Oct 11, 2006 | Substantially Equivalent | PETERS SURGICAL |
| K062307 | XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS | Sep 01, 2006 | Substantially Equivalent | ANULEX TECHNOLOGIES, INC |
| K060165 | AXYAFLEX POLYESTER SUTURE | Sep 01, 2006 | Substantially Equivalent | AXYA MEDICAL, INC. |
| K060367 | TENOLIG | Aug 09, 2006 | Substantially Equivalent | FOURNITURES HOSPITALIERES INDUSTRIE |
| K061386 | ANCHOR BAND SUTURING SYSTEM, MODEL SR-AB | Jul 05, 2006 | Substantially Equivalent | ANULEX TECHNOLOGIES, INC |
| K060721 | LARIAT LOOP APPLICATOR | Jun 02, 2006 | Substantially Equivalent | SENTREHEART |
| K053339 | ALLOFIX ANCHOR | Mar 16, 2006 | Substantially Equivalent | MUSCULOSKELETAL TRANSPLANT FOUNDATION |
| K050150 | MANI NEEDLE & SUTURE PACK | Dec 05, 2005 | Substantially Equivalent | MANI, INC. |
| K052652 | SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE | Oct 21, 2005 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K041512 | NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE | Jun 02, 2005 | Substantially Equivalent | SUTURES INDIA PRIVATE LIMITED |
| K042038 | MTF ALLOGRAFT ANCHOR | Dec 23, 2004 | Substantially Equivalent | MUSCULOSKELETAL TRANSPLANT FOUNDATION |
| K041553 | ARTHREX SUTURE GRAFTING KIT | Dec 10, 2004 | Substantially Equivalent | ARTHREX, INC. |
| K042286 | UNIESTER C | Dec 01, 2004 | Substantially Equivalent | UNITED MEDICAL INDUSTRIES CO. LTD. |
| K042031 | OPUS SPEEDSTITCH SUTURE DEVICE | Oct 19, 2004 | Substantially Equivalent | OPUS MEDICAL, INC. |
| K041894 | ORTHOFIBER | Sep 17, 2004 | Substantially Equivalent | CP MEDICAL |
| K041589 | ARTHREX FIBERWIRE WITH SILK | Aug 05, 2004 | Substantially Equivalent | ARTHREX, INC. |
| K041216 | SMITH & NEPHEW ULTRABRAID SUTURE | Jun 07, 2004 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K040789 | DURABRAID SUTURE | Jun 04, 2004 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K040472 | FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE | Mar 15, 2004 | Substantially Equivalent | TELEFLEX MEDICAL |
| K040232 | LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999 | Mar 01, 2004 | Substantially Equivalent | LSI SOLUTIONS |
| K033718 | MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE | Feb 12, 2004 | Substantially Equivalent | ARTHROTEK, INC. |
| K033654 | FORCE FIBER | Jan 15, 2004 | Substantially Equivalent | TELEFLEX MEDICAL |
| K032245 | ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239 | Jan 14, 2004 | Unknown | ARTHREX, INC. |
| K032901 | STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM | Dec 02, 2003 | Substantially Equivalent | Stryker Endoscopy |
| K023030 | DEMETECH POLYESTER NONABSORBABLE SUTURE | Jun 18, 2003 | Substantially Equivalent | DEMETECH CORP. |
| K021434 | ARTHREX FIBERWIRE IN USP SIZES | Nov 07, 2002 | Substantially Equivalent | ARTHREX, INC. |
| K022410 | SAPH-LOOP LIGATING LOOP | Aug 20, 2002 | Substantially Equivalent | GENZYME BIOSURGERY |
| K021019 | COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE | Jun 18, 2002 | Substantially Equivalent | GENZYME CORP. |
| K020902 | SERRALESTER | May 20, 2002 | Substantially Equivalent | SERRAL, S.A. DE C.V. |
| K013990 | LIFESTITCH SUTURING DEVICE | Feb 27, 2002 | Substantially Equivalent | EDWARDS LIFESCIENCES, LLC. |
| K012923 | ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201 | Oct 04, 2001 | Substantially Equivalent | ARTHREX, INC. |
| K012201 | PREMICRON NONABSORBABLE PET SURGICAL SUTURE | Sep 19, 2001 | Substantially Equivalent | AESCULAP, INC. |
| K002172 | POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS) | Aug 28, 2001 | Substantially Equivalent | XIROS PLC |
| K010673 | ARTHREX FIBERWIRE, MODEL SPU-02NB-3800 | May 14, 2001 | Substantially Equivalent | ARTHREX, INC. |
| K003590 | GRAMS POLYESTER NONABSORBABLE SUTURE | Mar 05, 2001 | Substantially Equivalent | GRAMSMED LLC |
| K001440 | NEXTSTITCH CARDIOVASCULAR VALVE SUTURE | Nov 13, 2000 | Substantially Equivalent | GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
| K001172 | POLYESTER NONABSORBABLE SURGICAL SUTURES URP | Jun 23, 2000 | Substantially Equivalent for Some Indications | CP MEDICAL |
| K001434 | 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE | Jun 12, 2000 | Substantially Equivalent for Some Indications | GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
| K000540 | POLYESTER NONABSORBABLE SURGICAL SUTURES, USP | Apr 27, 2000 | Substantially Equivalent for Some Indications | ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. |
| K994000 | POLYESTER | Feb 04, 2000 | Substantially Equivalent | TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. |
| K990952 | NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES | Apr 01, 1999 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K984550 | PRE-THREADED ENDOBUTTON | Mar 01, 1999 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K990088 | SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE | Feb 10, 1999 | Substantially Equivalent | AESCULAP, INC. |
| K972911 | AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER | Apr 25, 1998 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K980155 | ENDOBUTTON CONTINUOUS LOOP | Apr 01, 1998 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K970416 | ACUFEX DOUBLE ARMED SUTURE NEEDLE | Apr 21, 1997 | Substantially Equivalent | SMITH & NEPHEW ENDOSCOPY, INC. |
| K961925 | POLYESTER NONABSORBABLE SURGICAL SUTURES USP | Jul 29, 1996 | Substantially Equivalent for Some Indications | R.K. MEDICAL, L.L.C. |
| K961025 | EXPANDED BODY SUTURE | Apr 15, 1996 | Substantially Equivalent for Some Indications | MEDICINE LODGE, INC. |
| K955747 | USSC NONABSORBABLE SUTURES | Feb 27, 1996 | Substantially Equivalent for Some Indications | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K952535 | ACUFEX ENDOBUTTON TAPE | Feb 08, 1996 | Substantially Equivalent for Some Indications | ACUFEX MICROSURGICAL, INC. |
| K943221 | SURGIBOND | Dec 05, 1994 | Substantially Equivalent for Some Indications | SUTURES LTD. |
| K943220 | SUTULENE | Dec 05, 1994 | Substantially Equivalent for Some Indications | SUTURES LTD. |
| K943949 | POLYVIOLENE SURGICL SUTURE | Nov 10, 1994 | Substantially Equivalent for Some Indications | LOOK, INC. |
| K931916 | SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER | Mar 03, 1994 | Substantially Equivalent | SURGIMETRICS INTERNATIONAL, LTD. |
| K932038 | SUTURE NONABSORBABLE- SILK, POLYESTER | Jan 07, 1994 | Substantially Equivalent | SURGICAL SPECIALTIES, INC. |
| K930945 | BRAIDED POLYESTER SURGICAL SUTURE | Dec 17, 1993 | Substantially Equivalent | LUKENS MEDICAL CORP. |
| K930942 | LUKENS SILK SURGICAL SUTURE | Dec 17, 1993 | Substantially Equivalent | LUKENS MEDICAL CORP. |
| K930591 | TI-CRON AND DACRON SUTURES | Dec 17, 1993 | Substantially Equivalent | DAVIS & GECK, INC. |
| K930590 | SILK SUTURES | Dec 17, 1993 | Substantially Equivalent | DAVIS & GECK, INC. |
| K926167 | POLYVIOLENE SUTURE-REVISED LABELING | Dec 17, 1993 | Substantially Equivalent | LOOK, INC. |
| K920421 | MEDSURG MARSHMALLOW TRAY | Dec 13, 1993 | Unknown | MEDSURG INDUSTRIES, INC. |
FEI Numbers
This FDA classification entry is associated with 233 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 233 registration numbers. Click on an entry to view related FDA registrations.