EXCELLAGEN— 510(k) K110318

Substantially Equivalent

Tissue Repair Company

FDA 510(k) clearance K110318 for EXCELLAGEN, Substantially Equivalent on 2011-10-03. Applicant: Tissue Repair Company.

Clearance details

Applicant: Tissue Repair Company
Product code: Code KGN
Advisory panel: Unknown
Date received: 2011-02-02
Decision date: 2011-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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.