ClearanceBrief
510(k) K260711 ยท KGN Wound Dressing With Animal-Derived Material(S)

Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)

ApplicantBerkeley Advanced Biomaterials, Berkeley CA, US
DecisionSubstantially Equivalent, Aug 27, 2026
ReceivedMar 5, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K260711

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.