# 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-1

**Predicate Speed & CAPA Advisory Opportunity Score:** 54/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260920 |
| Device | 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) |
| Applicant | Berkeley Advanced Biomaterials |
| Specialty / panel | Other |
| Product code | KGN |
| Device class | U |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-03-19 |
| Decision date | 2026-10-22 |
| Review time (days) | 217 |
| Third-party review | No |
| Applicant location | Berkeley, CA, US |

## Why this score
- 217-day review, longer than typical.
- Posted 14 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260920). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.