# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Berkeley Advanced Biomaterials
- Decided: Aug 27, 2026 after 175 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K960978 (1996). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220498: NovoGen Wound Matrix, Novabone Products, LLC (2023) Summary page 5.

## Indications for use
Accelagen Plus Surgical Matrix is indicated for the management of wounds including: • Partial and full-thickness wounds • Pressure ulcers (stage I-IV) • Venous ulcers • Diabetic ulcers • Chronic vascular ulcers • Ulcers caused by mixed vascular etiologies • Tunneled/undermined wounds • Surgical wounds (e.g., incisions, donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence) • Trauma wounds (e.g., abrasions, lacerations, partial thickness burns and skin tears) • Draining wounds • First-degree burns and superficial second-degree burns.

Source page: https://510kreport.com/device/K260711
Methodology: https://510kreport.com/methodology