GAT
- 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)
- 14
- Summaries archived here
- 13 (direct download)
- 510(k) clearances (all years, FDA)
- 176 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (14)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253910 | 2026-08-22 | GM Dos Reis Industria e Comercio Ltda. | Stitch - Suture Wires and Tapes | |
| K261021 | 2026-07-01 | Winter Innovations, Inc. | EasyWhip Family | |
| K260775 | 2026-05-06 | Teleflex Medical, LLC | Polyethylene;Polyethylene Fusion;Polyethylene OrthoT… | |
| K254275 | 2026-03-23 | Threadstone, LLC | HyperSuture All Green Extension Line | |
| K254188 | 2026-02-19 | GM Dos Reis Industria e Comercio Ltda. | Meniscus Versaflex | |
| K253145 | 2025-10-22 | Rti Surgical, Inc. | Pre-Sutured Tendon | |
| K253024 | 2025-10-16 | Riverpoint Medical | ProZip Knotless Implant | |
| K252225 | 2025-09-12 | Medacta International S.A. | PowerKnot High Strength Sutures | |
| K252201 | 2025-08-13 | Riverpoint Medical | HS Fiber | |
| K242201 | 2025-03-27 | Threadstone, LLC | HyperSuture White/Green Extension Line | |
| K241376 | 2024-08-09 | Threadstone, LLC | HyperSuture All Blue Extension Line | |
| K234079 | 2024-05-10 | Threadstone, LLC | HyperSuture Extension Line | |
| K231163 | 2024-01-05 | Riverpoint Medical | HS Fiber Sutures | |
| K230311 | 2023-11-24 | Threadstone, LLC | HyperSuture | FDA |
Official FDA classification page: GAT
Classification and pathway per current FDA publications. Data from openFDA (CC0).