K251845 is an FDA 510(k) clearance for the Marigen Wound Extra. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Kerecis Limited (Isafjordur, IS). The FDA issued a Cleared decision on July 16, 2025, 30 days after receiving the submission on June 16, 2025.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K251845 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2025 |
| Decision Date | July 16, 2025 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KGN - Wound Dressing With Animal-derived Material(s) |
| Device Class | - |