K260711

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)

510(k) number: K260711
Device name: 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 CA · US
Product code: KGN — Wound Dressing With Animal-Derived Material(S)
Decision date: 2026-08-27
Date received: 2026-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Unknown

510(k) Summary (official FDA PDF): K260711.pdf

Official FDA record: K260711

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.