FTM — Mesh, Surgical Class II
FDA product code FTM covers "Mesh, Surgical", a Class II medical device regulated under 21 CFR 878.3300. 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
- FTM
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250598 | aroa biosurgery | Endoform Reconstructive Template - PLGA | June 3, 2025 |
| K243595 | tela bio | OviTex PRS (Long-Term Resorbable) | December 19, 2024 |
| K233991 | elutia | CanGaroo RM Antibacterial Envelope | June 14, 2024 |
| K241126 | tela bio | OviTex PRS | May 22, 2024 |
| K223052 | synovis life technologies | Peri-Guard and Supple Peri-Guard | April 7, 2023 |
| K214070 | tela bio | OviTex PRS (Long Term Resorbable) | March 21, 2023 |
| K213163 | alafair biosciences | VersaWrap | October 29, 2021 |
| K213125 | synovis life technologies. inc. (a subsidiary of baxter | PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECU | October 27, 2021 |
| K203496 | geistlich pharma | Nexo-Gide Bilayer Collagen Membrane | July 14, 2021 |
| K203600 | alafair biosciences | VersaWrap | March 9, 2021 |
| K192452 | b. bruan surgical | Lyograft | September 3, 2020 |
| K201000 | cook biotech incorporated | Biodesign Staple Line Reinforcement | July 13, 2020 |
| K201313 | aziyo biologics | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large) | June 15, 2020 |
| K200311 | alafair biosciences | VersaWrap Tendon Protector | March 6, 2020 |
| K192615 | synovis life technologies, inc. (baxter international inc.) | Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-S | December 17, 2019 |
| K192616 | aziyo biologics | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large) | October 21, 2019 |
| K182493 | tisgenx | Bovine Pericardial Tissue Patch | June 18, 2019 |
| K183398 | aroa biosurgery | Endoform Restella | April 11, 2019 |
| K183472 | synthes (usa) products | DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio MR Con | March 13, 2019 |
| K182259 | acell | Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal | February 7, 2019 |