K250329 is an FDA 510(k) clearance for the GeniPhys Collymer Self-Assembling Scaffold. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Geniphys, Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 25, 2025, 140 days after receiving the submission on February 5, 2025.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K250329 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2025 |
| Decision Date | June 25, 2025 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KGN - Wound Dressing With Animal-derived Material(s) |
| Device Class | - |