Accelagen Plus Surgical Matrix, 1cc (CG-01AP) +4 more— 510(k) K260711

Name: FDA 510(k) clearance K260711
Creator: U.S. Food and Drug Administration
Published: 2026-08-27

Substantially Equivalent

Berkeley 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.

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: Code KGN
Device class: Unclassified
Advisory panel: Unknown
Date received: 2026-03-05
Decision date: 2026-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berkeley, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KGN

product code KGN

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.