K243595 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, Inc. (Malvern, US). The FDA issued a Cleared decision on December 19, 2024, 29 days after receiving the submission on November 20, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K243595 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 20, 2024 |
| Decision Date | December 19, 2024 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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 |