GAT · Suture, Nonabsorbable, Synthetic, Polyethylene
General, Plastic Surgery · 21 CFR 878.5000 · Class 2
Overview
| Product Code | GAT |
|---|---|
| Device Name | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Regulation | 21 CFR 878.5000 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.
Classification Rationale
Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
Recent Cleared Devices (20 of 173)
Showing 20 most recent of 173 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K254275 | HyperSuture All Green Extension Line | Threadstone, LLC | Mar 23, 2026 | SESE |
| K254188 | Meniscus Versaflex | GM Dos Reis Industria e Comercio Ltda. | Feb 19, 2026 | SESE |
| K253145 | Pre-Sutured Tendon | Rti Surgical, Inc. | Oct 22, 2025 | SESE |
| K253024 | ProZip Knotless Implant | Riverpoint Medical | Oct 16, 2025 | SESE |
| K252225 | PowerKnot High Strength Sutures | Medacta International S.A. | Sep 12, 2025 | SESE |
| K252201 | HS Fiber | Riverpoint Medical | Aug 13, 2025 | SESE |
| K242201 | HyperSuture White/Green Extension Line | Threadstone, LLC | Mar 27, 2025 | SESE |
| K241376 | HyperSuture All Blue Extension Line | Threadstone, LLC | Aug 9, 2024 | SESE |
| K234079 | HyperSuture Extension Line | Threadstone, LLC | May 10, 2024 | SESE |
| K231163 | HS Fiber Sutures | Riverpoint Medical | Jan 5, 2024 | SESE |
| K230311 | HyperSuture | Threadstone, LLC | Nov 24, 2023 | SESE |
| K231183 | Non absorbable Surgical Polyester Suture | Shandong Haidike Medical Products Co., Ltd. | Aug 25, 2023 | SESE |
| K223500 | SuperBall Meniscal Repair System | Arcuro Medical , Ltd. | Aug 10, 2023 | SESE |
| K223122 | MENIX®; MENIX® DUO | S.B.M. Sas (Science & Bio Materials) | Aug 3, 2023 | SESE |
| K230510 | MyEllevate | Cynosure, LLC | Jul 6, 2023 | SESE |
| K213046 | AceConnex Pre-Sutured Fascia | Allosource | Jun 27, 2023 | SESE |
| K230036 | Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) | Rti Surgical, Inc. | Jun 23, 2023 | SESE |
| K223822 | ACTIVBRAID | Embody, Inc. | Jun 2, 2023 | SESE |
| K220880 | Arthrex BioSuture | Arthrex, Inc. | Oct 27, 2022 | SESE |
| K222078 | Arthrex SoftStitch | Arthrex, Inc. | Sep 14, 2022 | SESE |
Top Applicants
- Arthrex, Inc. — 19 clearances
- Smith & Nephew, Inc. — 11 clearances
- Riverpoint Medical — 6 clearances
- Medos International SARL — 5 clearances
- Teleflex Medical — 5 clearances
