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)
| Applicant | Berkeley Advanced Biomaterials, Berkeley CA, US |
| Decision | Substantially Equivalent, Aug 27, 2026 |
| Received | Mar 5, 2026 |
| Type | Traditional |
| FDA record | Open 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.