Accelagen Plus Surgical Matrix, 1cc (CG-01AP) +4 more— 510(k) K260711
Substantially EquivalentBerkeley Advanced Biomaterials
FDA 510(k) clearance K260711 for Accelagen Plus Surgical Matrix, 1cc (CG-01AP) +4 more, Substantially Equivalent on 2026-08-27. Applicant: Berkeley Advanced Biomaterials. Device class: Unclassified.
Summary
Berkeley Advanced Biomaterials filed Accelagen Plus in five listed sizes: Surgical Matrix in 1cc, 3cc, and 5cc (CG-01AP, CG-03AP, CG-05AP) and Surgical Strip in 125x25x2mm and 250x25x2mm (CG-125X25AP, CG-250X25AP). The product code is KGN, wound dressings with animal-derived material.
The device class is listed as U, with no regulation number, and the classification panel is listed as Unknown. The General and Plastic Surgery review panel handled it as a Traditional 510(k).
The applicant filed from Berkeley, California. The decision came 175 calendar days after receipt (March 5 to August 27, 2026), and it was substantially equivalent.
Clearance details
- Device name as filed
- 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
- Product code
- Product code KGN
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Berkeley, CA, US
Recent devices under product code KGN
view allMore clearances from Berkeley Advanced Biomaterials
view allAdverse events under product code KGN
product code KGN- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.