510(k) clearance

Accelagen Advanced Surgical Collagen Matrix, 1cc (CG-01AA); Accelagen Advanced Surgical Collagen Matrix, 2cc (CG-02AA); Accelagen Advanced Surgical Collagen Matrix, 3cc (CG-03AA); Accelagen Advanced Surgical Collagen Matrix, 5cc (CG-05AA); Accelagen Advanced Surgical Collagen Strip, 125x25x2mm (CG-125X25AA); Accelagen Advanced Surgical Collagen Strip, 250x25x2mm (CG-250X25AA)

FDA 510(k) source

510(k) number

K260920

Applicant

Berkeley Advanced Biomaterials

Decision date

Oct 22, 2026

Date received

Mar 19, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

KGN

Device type

Wound Dressing With Animal-Derived Material(S)

Device class

Unclassified

Advisory committee

Unknown

Statement or summary

Summary

Third party

N

Location

Berkeley, CA, US