GAT — Suture, Nonabsorbable, Synthetic, Polyethylene Class II
FDA product code GAT covers "Suture, Nonabsorbable, Synthetic, Polyethylene", a Class II medical device regulated under 21 CFR 878.5000. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GAT
- Device Class
- Class II
- Regulation Number
- 878.5000
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261021 | winter innovations | EasyWhip Family | July 1, 2026 |
| K260775 | teleflex medical | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape | May 6, 2026 |
| K254275 | threadstone | HyperSuture All Green Extension Line | March 23, 2026 |
| K254188 | gm dos reis industria e comercio ltda | Meniscus Versaflex | February 19, 2026 |
| K253145 | rti surgical | Pre-Sutured Tendon | October 22, 2025 |
| K253024 | riverpoint medical | ProZip Knotless Implant | October 16, 2025 |
| K252225 | medacta international | PowerKnot High Strength Sutures | September 12, 2025 |
| K252201 | riverpoint medical | HS Fiber | August 13, 2025 |
| K242201 | threadstone | HyperSuture White/Green Extension Line | March 27, 2025 |
| K241376 | threadstone | HyperSuture All Blue Extension Line | August 9, 2024 |
| K234079 | threadstone | HyperSuture Extension Line | May 10, 2024 |
| K231163 | riverpoint medical | HS Fiber Sutures | January 5, 2024 |
| K230311 | threadstone | HyperSuture | November 24, 2023 |
| K231183 | shandong haidike medical products co | Non absorbable Surgical Polyester Suture | August 25, 2023 |
| K223500 | arcuro medical | SuperBall Meniscal Repair System | August 10, 2023 |
| K223122 | s.b.m. sas (science and bio materials) | MENIX®; MENIX® DUO | August 3, 2023 |
| K230510 | cynosure | MyEllevate | July 6, 2023 |
| K213046 | allosource | AceConnex Pre-Sutured Fascia | June 27, 2023 |
| K230036 | rti surgical | Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadru | June 23, 2023 |
| K223822 | embody | ACTIVBRAID | June 2, 2023 |