COLLAGEN SPONGE— 510(k) K092805

Substantially Equivalent

Innocoll Pharmaceuticals

FDA 510(k) clearance K092805 for COLLAGEN SPONGE, Substantially Equivalent on 2010-02-16. Applicant: Innocoll Pharmaceuticals.

Clearance details

Applicant: Innocoll Pharmaceuticals
Product code: Code KGN
Advisory panel: Unknown
Date received: 2009-09-11
Decision date: 2010-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Athlone, Co. Westmeath, IE

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.