GAT — Suture, Nonabsorbable, Synthetic, Polyethylene Class II
FDA Device Classification
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 |
|---|
| 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 |
| K220880 | arthrex | Arthrex BioSuture | October 27, 2022 |
| K222078 | arthrex | Arthrex SoftStitch | September 14, 2022 |
| K221354 | arthrex | Arthrex SutureTape | September 9, 2022 |