K232373 is an FDA 510(k) clearance for the Progrip? Self-Gripping Polypropylene Mesh, a Mesh, Surgical, Polymeric (Class II — Special Controls, product code FTL), submitted by Sofradim Production (Tr?voux, FR). The FDA issued a Cleared decision on January 18, 2024, 163 days after receiving the submission on August 8, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K232373 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 08, 2023 |
| Decision Date | January 18, 2024 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTL — Mesh, Surgical, Polymeric |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.3300 |