ClearanceBrief
510(k) K253521 ยท KGN Wound Dressing With Animal-Derived Material(S)

ECMT-100 WMD

ApplicantEcm Therapeutics, Inc., Warrendale PA, US
DecisionSubstantially Equivalent, Jun 18, 2026
ReceivedNov 13, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K253521

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.