K172395 is an FDA 510(k) clearance for the Duatene bilayer mesh. This device is classified as a Mesh, Surgical, Polymeric (Class II - Special Controls, product code FTL).
Submitted by Sofradim Production (Trévoux, FR). The FDA issued a Cleared decision on February 1, 2018, 177 days after receiving the submission on August 8, 2017.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K172395 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 2017 |
| Decision Date | February 01, 2018 |
| Days to Decision | 177 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 |