510(k) clearance
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
- Applicant
- Berkeley Advanced Biomaterials
- Decision date
- Aug 27, 2026
- Date received
- Mar 5, 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