510(k) K251845 ยท KGN Wound Dressing With Animal-Derived Material(S)
Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus
| Applicant | Kerecis Limited, Isafjordur, IS |
| Decision | Substantially Equivalent, Jul 16, 2025 |
| Received | Jun 16, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K251845
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.