K241126 is an FDA 510(k) clearance for the OviTex PRS. This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).
Submitted by TELA Bio, Inc. (Malvern, US). The FDA issued a Cleared decision on May 22, 2024, 29 days after receiving the submission on April 23, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K241126 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 2024 |
| Decision Date | May 22, 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 |