K241904 is an FDA 510(k) clearance for the DermiSphere Dermal Template. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Fesariustherapeutics, Inc. (Brooklyn, US). The FDA issued a Cleared decision on January 6, 2025, 189 days after receiving the submission on July 1, 2024.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K241904 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2024 |
| Decision Date | January 06, 2025 |
| Days to Decision | 189 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 | - |