FDA Product Code
FDA Product Code GAT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.5000
510(k) Clearances — 176 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253910 | Stitch - Suture Wires and Tapes | GM Dos Reis Industria e Comercio Ltda. | 2026-08-22 | Traditional | PDF ↗ |
| K261021 | EasyWhip Family | Winter Innovations, Inc. | 2026-07-01 | Traditional | PDF ↗ |
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape | Teleflex Medical, LLC | 2026-05-06 | Traditional | PDF ↗ |
| K254275 | HyperSuture All Green Extension Line | Threadstone, LLC | 2026-03-23 | Traditional | PDF ↗ |
| K254188 | Meniscus Versaflex | GM Dos Reis Industria e Comercio Ltda. | 2026-02-19 | Traditional | PDF ↗ |
| K253145 | Pre-Sutured Tendon | Rti Surgical, Inc. | 2025-10-22 | Special | PDF ↗ |
| K253024 | ProZip Knotless Implant | Riverpoint Medical | 2025-10-16 | Special | PDF ↗ |
| K252225 | PowerKnot High Strength Sutures | Medacta International S.A. | 2025-09-12 | Traditional | PDF ↗ |
| K252201 | HS Fiber | Riverpoint Medical | 2025-08-13 | Special | PDF ↗ |
| K242201 | HyperSuture White/Green Extension Line | Threadstone, LLC | 2025-03-27 | Traditional | PDF ↗ |
| K241376 | HyperSuture All Blue Extension Line | Threadstone, LLC | 2024-08-09 | Traditional | PDF ↗ |
| K234079 | HyperSuture Extension Line | Threadstone, LLC | 2024-05-10 | Traditional | PDF ↗ |
| K231163 | HS Fiber Sutures | Riverpoint Medical | 2024-01-05 | Traditional | PDF ↗ |
| K230311 | HyperSuture | Threadstone, LLC | 2023-11-24 | Traditional | PDF ↗ |
| K231183 | Non absorbable Surgical Polyester Suture | Shandong Haidike Medical Products Co., Ltd. | 2023-08-25 | Traditional | PDF ↗ |
| K223500 | SuperBall Meniscal Repair System | Arcuro Medical , Ltd. | 2023-08-10 | Traditional | PDF ↗ |
| K223122 | MENIX®; MENIX® DUO | S.B.M. Sas (Science & Bio Materials) | 2023-08-03 | Traditional | PDF ↗ |
| K230510 | MyEllevate | Cynosure, LLC | 2023-07-06 | Traditional | PDF ↗ |
| K213046 | AceConnex Pre-Sutured Fascia | Allosource | 2023-06-27 | Traditional | PDF ↗ |
| K230036 | Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) | Rti Surgical, Inc. | 2023-06-23 | Traditional | PDF ↗ |
| K223822 | ACTIVBRAID | Embody, Inc. | 2023-06-02 | Traditional | PDF ↗ |
| K220880 | Arthrex BioSuture | Arthrex, Inc. | 2022-10-27 | Special | PDF ↗ |
| K222078 | Arthrex SoftStitch | Arthrex, Inc. | 2022-09-14 | Traditional | PDF ↗ |
| K221354 | Arthrex SutureTape | Arthrex, Inc. | 2022-09-09 | Special | PDF ↗ |
| K220186 | Zone Specific AIM | Conmed Corporation | 2022-05-13 | Traditional | PDF ↗ |
| K220219 | PERMALOOP Suture, PERMATAPE Suture | Medos International SARL | 2022-04-26 | Traditional | PDF ↗ |
| K212146 | Arthrex LoopLoc Knotless Suture | Arthrex, Inc. | 2021-10-25 | Traditional | PDF ↗ |
| K210675 | EasyWhip | Winter Innovations, Inc. | 2021-05-03 | Traditional | PDF ↗ |
| K203186 | DYNATAPE Suture | Medos International SARL | 2021-03-18 | Traditional | PDF ↗ |
| K203393 | FAST-FIX FLEX | Smith & Nephew, Inc. | 2021-02-01 | Traditional | PDF ↗ |
| K190707 | Arthrex SoftStitch | Arthrex, Inc. | 2020-10-02 | Traditional | PDF ↗ |
| K202242 | HS Fiber | Riverpoint Medical, LLC | 2020-09-10 | Special | PDF ↗ |
| K193575 | Arthrex SutureTape | Arthrex, Inc. | 2020-07-24 | Traditional | PDF ↗ |
| K192490 | Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch | Teleflex Medical | 2020-03-30 | Traditional | PDF ↗ |
| K192637 | High Strength Suture | Yunyi (Beijing) Medical Device Co., Ltd. | 2020-03-02 | Traditional | PDF ↗ |
| K190777 | DemeTECH DemeFORCE Nonabsorbable Surgical Suture | Demetech Corporation | 2019-07-31 | Traditional | PDF ↗ |
| K191268 | Force Fiber Suture | Teleflex Medical Incorporated | 2019-06-11 | Special | PDF ↗ |
| K190817 | HS Fiber | Riverpoint Medical | 2019-05-01 | Special | PDF ↗ |
| K181633 | MTF Pre-Sutured Tendon | Musculoskeletal Transplant Foundation | 2019-03-15 | Traditional | PDF ↗ |
| 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 | Teleflex Medical Incorporated | 2018-10-10 | Traditional | PDF ↗ |
| K181182 | DYNACORD Suture | Medos International SARL | 2018-08-02 | Traditional | PDF ↗ |
| K181772 | NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) | Ceterix Orthopaedics, Inc. | 2018-08-01 | Special | PDF ↗ |
| K180191 | SuperBall Meniscal Repair System | Arcuro Medical , Ltd. | 2018-06-05 | Traditional | PDF ↗ |
| K180531 | NovoStitch Pro Meniscal Repair System | Ceterix Orthopaedics, Inc. | 2018-03-29 | Special | PDF ↗ |
| K170957 | ReConnex Pre-Sutured Tendon | Allosource | 2018-03-20 | Traditional | PDF ↗ |
| K172016 | Force Fiber Fusion Suture | Teleflex Medical Incorporated | 2017-10-03 | Traditional | PDF ↗ |
| K170642 | GRAVITY Soft Tissue Repair System | Wrightmedicaltechnologyinc | 2017-08-22 | Traditional | PDF ↗ |
| K171680 | Infinity-Lock 3, Infinity-Lock 5 | Xiros, Ltd. | 2017-06-30 | Special | PDF ↗ |
| K171296 | SutureTape | Arthrex, Inc. | 2017-05-26 | Special | PDF ↗ |
| K163651 | ExpressBraid Graft Manipulation | Biomet Manufacturing Corp | 2017-02-17 | Traditional | PDF ↗ |
| K163142 | SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader | ArthroCare Corporation | 2017-01-06 | Special | PDF ↗ |
| K160854 | MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture | Biomet Manafacturing Corp. | 2016-12-19 | Traditional | PDF ↗ |
| K162247 | PERMATAPE | Medos International SARL | 2016-12-15 | Traditional | PDF ↗ |
| K162310 | XBraid TT Suture Tape | Stryker | 2016-11-10 | Traditional | PDF ↗ |
| K161638 | SPEEDTRAP Graft Preparation System | Medos International SARL | 2016-11-07 | Traditional | PDF ↗ |
| K153089 | 'cottony' II TAPE, PLEDGETS | Teleflexmedical, Inc. | 2016-08-12 | Traditional | PDF ↗ |
| K153087 | IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved | Ivy Sports Medicine, LLC | 2016-07-14 | Traditional | PDF ↗ |
| K153076 | silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL | Teleflexmedical, Inc. | 2016-06-16 | Traditional | PDF ↗ |
| K153746 | Dunamis Force DFX Tensile Tape | Dunamis, LLC | 2016-03-03 | Traditional | PDF ↗ |
| K153307 | HS SutureTape | Riverpoint Medical | 2016-02-12 | Special | PDF ↗ |
| K152868 | ExpressBraid Graft Manipulation | Biomet Manufacturing Corp | 2016-02-08 | Traditional | PDF ↗ |
| K153096 | LARIAT RS Suture Delivery Device | Sentreheart, Inc. | 2015-11-25 | Special | PDF ↗ |
| K151758 | ALAR Nasal Valve Stent | Medtronic Xomed, Inc. | 2015-10-29 | Traditional | PDF ↗ |
| K151009 | Nexus Suture | Baylis Medical Company, Inc. | 2015-08-18 | Traditional | PDF ↗ |
| K150584 | Stryker Suture Tape | Stryker | 2015-08-13 | Traditional | PDF ↗ |
| K143356 | NovoStitch Plus Meniscal Repair System | Ceterix Orthopaedics, Inc. | 2015-07-21 | Traditional | PDF ↗ |
| K150327 | Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2 | Dunamis, LLC | 2015-06-29 | Traditional | PDF ↗ |
| K150438 | Force Fiber OrthoTape suture | Teleflexmedical, Inc. | 2015-04-02 | Special | PDF ↗ |
| K142241 | LARIAT sulture Delivery Device | Sentreheart, Inc. | 2014-09-12 | Special | PDF ↗ |
| K141072 | SUPOLENE | Resorba Medical GmbH | 2014-06-23 | Traditional | PDF ↗ |
| K133770 | A.I.M. KNOTLESS MENISCAL REPAIR DEVICE | Anchor Innovation Medical (A.I.M.) | 2014-06-10 | Traditional | PDF ↗ |
| K140019 | ARTHREX BIOSUTURE | Arthrex, Inc. | 2014-01-30 | Special | PDF ↗ |
| K132079 | TFCC FAST-FIX KIT | Smith & Nephew, Inc. | 2013-12-05 | Traditional | PDF ↗ |
| K132357 | SMITH & NEPHEW ULTRATAPE | Smith & Nephew, Inc. | 2013-10-30 | Special | PDF ↗ |
| K132043 | ARTHREX SPEEDCINCH | Arthrex, Inc. | 2013-07-31 | Special | PDF ↗ |
| K122735 | SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2 | Sorin Group USA, Inc. | 2013-05-21 | Traditional | PDF ↗ |
| K123268 | SMARTSTITCH PERFECTPASSER SYSTEM | Arthocare Corporation | 2012-11-07 | Special | PDF ↗ |
| K121861 | SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N | Smith & Nephew, Inc. | 2012-10-18 | Traditional | PDF ↗ |
| K122374 | ARTHREX SUTURE (UHMWPE) | Arthrex, Inc. | 2012-09-25 | Special | PDF ↗ |
| K121306 | SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE | Arthocare Corporation | 2012-07-12 | Traditional | PDF ↗ |
| K121413 | CROSSFIX II MEMISCAL REPAIR DEVICE | Cayenne Medical, Inc. | 2012-06-04 | Special | PDF ↗ |
| K112899 | ARTHREX BIO-SUTURE | Arthrex, Inc. | 2012-04-06 | Traditional | PDF ↗ |
| K101377 | SMITH & NEWPHEW ULTRABRAID II SUTURE | Smith & Newphew, Inc. | 2011-04-08 | Traditional | PDF ↗ |
| K102339 | CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE | Conmed Linvatec | 2010-11-23 | Traditional | PDF ↗ |
| K103052 | V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE | Covidien, LLC | 2010-11-10 | Traditional | PDF ↗ |
| K102916 | G-CATH TISSUE ANCHOR DELIVERY CATHETER | Usgi Medical | 2010-10-20 | Special | PDF ↗ |
| K102028 | NEOTRACT ANCHOR SYSTEM MODEL TAS400 | Neotract, Inc. | 2010-08-04 | Special | PDF ↗ |
| K101252 | NEOTRACT ANCHOR SYSTEM MODEL: REF 11208 | Neotract, Inc. | 2010-07-15 | Traditional | PDF ↗ |
| K100006 | HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED | Riverpoint Medical | 2010-05-10 | Abbreviated | PDF ↗ |
| K094028 | CP-FIBER (ORTHOFIBER) | Cp Medical | 2010-03-18 | Abbreviated | PDF ↗ |
| K100572 | VERSACLOSE, MODEL VC-200-01 | Anulex Technologies, Inc. | 2010-03-17 | Special | PDF ↗ |
| K100506 | FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK | Teleflex Medical | 2010-03-10 | Special | PDF ↗ |
| K100251 | G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333 | Usgi Medical | 2010-02-17 | Special | PDF ↗ |
| K092508 | FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT, | Smith & Nephew, Inc. | 2010-01-28 | Traditional | PDF ↗ |
| K091061 | IMPLICITGUIDE SURGICAL SUTURE SYSTEM | Implicitcare, LLC | 2009-11-13 | Traditional | PDF ↗ |
| K091574 | SILK BLACK BRAIDED SURGICAL SUTURES, NYLON MONOFILAMENT BLUE AND BLACK SURGICAL SUTURES | Supplidores Unidos Internacionales, S.A. | 2009-10-09 | Abbreviated | PDF ↗ |
| K093018 | G-PROX ENDOSCOPIC GRASPER, MODEL 205333 | Usgi Medical | 2009-10-07 | Special | PDF ↗ |
| K092533 | FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES | Beere Precision Medical Instruments, Kmedic, Telef | 2009-09-15 | Special | PDF ↗ |
| K091432 | XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01 | Anulex Technologies, Inc. | 2009-06-12 | Special | PDF ↗ |
| K090385 | LARIAT II SUTURE DELIVERY DEVICE | Sentreheart, Inc. | 2009-05-06 | Traditional | PDF ↗ |
Product code GAT · Class II · General, Plastic Surgery. Data: openFDA.