FTM
- Product code
- FTM
- Device name
- Mesh, Surgical
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.3300
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 164 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K262406 | 2026-08-12 | Boston Scientific | EluPro Antibiotic-Eluting BioEnvelope | |
| K250598 | 2025-06-03 | Aroa Biosurgery , Ltd. | Endoform Reconstructive Template - PLGA | |
| K243595 | 2024-12-19 | TELA Bio, Inc. | OviTex PRS (Long-Term Resorbable) | |
| K233991 | 2024-06-14 | Elutia, Inc. | CanGaroo RM Antibacterial Envelope | FDA |
| K241126 | 2024-05-22 | TELA Bio, Inc. | OviTex PRS |
Official FDA classification page: FTM
Classification and pathway per current FDA publications. Data from openFDA (CC0).