ClearanceBrief
510(k) K260058 ยท KGN Wound Dressing With Animal-Derived Material(S)

Kerecis Express (50250)

ApplicantKerecis Limited, Isafjordur, IS
DecisionSubstantially Equivalent, Oct 30, 2026
ReceivedJan 8, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K260058

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.