K214070 is an FDA 510(k) clearance for the OviTex PRS (Long Term Resorbable), a Mesh, Surgical (Class II — Special Controls, product code FTM), submitted by Tela Bio (Malvern, US). The FDA issued a Cleared decision on March 21, 2023, 449 days after receiving the submission on December 27, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K214070 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 27, 2021 |
| Decision Date | March 21, 2023 |
| Days to Decision | 449 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTM — Mesh, Surgical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.3300 |