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GAT

Suture, Nonabsorbable, Synthetic, Polyethylene

Product code
GAT
Device name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device class
Class 2
21 CFR
21 CFR 878.5000
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
176

510(k) clearances, last 3 years (14)

Last three years. Most recent: 2026-08-22.

NumberDecision dateApplicantDevice name
K2539102026-08-22GM Dos Reis Industria e Comercio Ltda.Stitch - Suture Wires and Tapes summary
K2610212026-07-01Winter Innovations, Inc.EasyWhip Family summary
K2607752026-05-06Teleflex Medical, LLCPolyethylene;Polyethylene Fusion;Polyethylene OrthoT summary
K2542752026-03-23Threadstone, LLCHyperSuture All Green Extension Line summary
K2541882026-02-19GM Dos Reis Industria e Comercio Ltda.Meniscus Versaflex summary
K2531452025-10-22Rti Surgical, Inc.Pre-Sutured Tendon summary
K2530242025-10-16Riverpoint MedicalProZip Knotless Implant summary
K2522252025-09-12Medacta International S.A.PowerKnot High Strength Sutures summary
K2522012025-08-13Riverpoint MedicalHS Fiber summary
K2422012025-03-27Threadstone, LLCHyperSuture White/Green Extension Line summary
K2413762024-08-09Threadstone, LLCHyperSuture All Blue Extension Line summary
K2340792024-05-10Threadstone, LLCHyperSuture Extension Line summary
K2311632024-01-05Riverpoint MedicalHS Fiber Sutures summary
K2303112023-11-24Threadstone, LLCHyperSuture summary
Official FDA classification page: GAT
Classification and pathway per current FDA publications. Data from openFDA (CC0).