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
Aug 22, 2026K253910Stitch - Suture Wires and Tapes
GM Dos Reis Industria e Comercio Ltda., BR
GAT
Jul 1, 2026K261021EasyWhip Family
Winter Innovations, Inc.
GAT
May 6, 2026K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™
Teleflex Medical, LLC
GAT
Mar 23, 2026K254275HyperSuture All Green Extension Line
Threadstone, LLC
GAT
Feb 19, 2026K254188Meniscus Versaflex
GM Dos Reis Industria e Comercio Ltda., BR
GAT
Oct 22, 2025K253145Pre-Sutured Tendon
Rti Surgical, Inc.
GAT
Oct 16, 2025K253024ProZip Knotless Implant
Riverpoint Medical
GAT
Sep 12, 2025K252225PowerKnot High Strength Sutures
Medacta International S.A., CH
GAT
Aug 13, 2025K252201HS Fiber
Riverpoint Medical
GAT
Mar 27, 2025K242201HyperSuture White/Green Extension Line
Threadstone, LLC
GAT
Aug 9, 2024K241376HyperSuture All Blue Extension Line
Threadstone, LLC
GAT
May 10, 2024K234079HyperSuture Extension Line
Threadstone, LLC
GAT
Jan 5, 2024K231163HS Fiber Sutures
Riverpoint Medical
GAT
Nov 24, 2023K230311HyperSuture
Threadstone, LLC
GAT
Aug 25, 2023K231183Non absorbable Surgical Polyester Suture
Shandong Haidike Medical Products Co., Ltd., CN
GAT
Aug 10, 2023K223500SuperBall Meniscal Repair System
Arcuro Medical , Ltd., IL
GAT
Aug 3, 2023K223122MENIX®; MENIX® DUO
S.B.M. Sas (Science & Bio Materials), FR
GAT
Jul 6, 2023K230510MyEllevate
Cynosure, LLC
GAT
Jun 27, 2023K213046AceConnex Pre-Sutured Fascia
Allosource
GAT
Jun 23, 2023K230036Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )
Rti Surgical, Inc.
GAT
Jun 2, 2023K223822ACTIVBRAID™
Embody, Inc.
GAT
Oct 27, 2022K220880Arthrex BioSuture
Arthrex, Inc.
GAT
Sep 14, 2022K222078Arthrex SoftStitch
Arthrex, Inc.
GAT
Sep 9, 2022K221354Arthrex SutureTape
Arthrex, Inc.
GAT
May 13, 2022K220186Zone Specific AIM
Conmed Corporation
GAT
Apr 26, 2022K220219PERMALOOP Suture, PERMATAPE Suture
Medos International SARL, CH
GAT
Oct 25, 2021K212146Arthrex LoopLoc Knotless Suture
Arthrex, Inc.
GAT
May 3, 2021K210675EasyWhip
Winter Innovations, Inc.
GAT
Mar 18, 2021K203186DYNATAPE Suture
Medos International SARL, CH
GAT
Feb 1, 2021K203393FAST-FIX FLEX
Smith & Nephew, Inc.
GAT
Oct 2, 2020K190707Arthrex SoftStitch
Arthrex, Inc.
GAT
Sep 10, 2020K202242HS Fiber
Riverpoint Medical, LLC
GAT
Jul 24, 2020K193575Arthrex SutureTape
Arthrex, Inc.
GAT
Mar 30, 2020K192490Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch
Teleflex Medical
GAT
Mar 2, 2020K192637High Strength Suture
Yunyi (Beijing) Medical Device Co., Ltd., CN
GAT
Jul 31, 2019K190777DemeTECH DemeFORCE Nonabsorbable Surgical Suture
Demetech Corporation
GAT
Jun 11, 2019K191268Force Fiber Suture
Teleflex Medical Incorporated
GAT
May 1, 2019K190817HS Fiber
Riverpoint Medical
GAT
Mar 15, 2019K181633MTF Pre-Sutured Tendon
Musculoskeletal Transplant Foundation
GAT
Oct 10, 2018K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek sutur
Teleflex Medical Incorporated
GAT
Aug 2, 2018K181182DYNACORD Suture
Medos International SARL, CH
GAT
Aug 1, 2018K181772NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)
Ceterix Orthopaedics, Inc.
GAT
Jun 5, 2018K180191SuperBall Meniscal Repair System
Arcuro Medical , Ltd., IL
GAT
Mar 29, 2018K180531NovoStitch Pro Meniscal Repair System
Ceterix Orthopaedics, Inc.
GAT
Mar 20, 2018K170957ReConnex Pre-Sutured Tendon
Allosource
GAT
Oct 3, 2017K172016Force Fiber Fusion Suture
Teleflex Medical Incorporated
GAT
Aug 22, 2017K170642GRAVITY™ Soft Tissue Repair System
Wrightmedicaltechnologyinc
GAT
Jun 30, 2017K171680Infinity-Lock 3, Infinity-Lock 5
Xiros, Ltd., GB
GAT
May 26, 2017K171296SutureTape
Arthrex, Inc.
GAT
Feb 17, 2017K163651ExpressBraid Graft Manipulation
Biomet Manufacturing Corp
GAT

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