K203496 is an FDA 510(k) clearance for the Nexo-Gide Bilayer Collagen Membrane. This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).
Submitted by Geistlich Pharma AG (Wolhusen, CH). The FDA issued a Cleared decision on July 14, 2021, 229 days after receiving the submission on November 27, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K203496 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 2020 |
| Decision Date | July 14, 2021 |
| Days to Decision | 229 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 |