KENSEY NASH ECM SURGICAL PATCH— 510(k) K094061

Substantially Equivalent

Kensey Nash Corporation

FDA 510(k) clearance K094061 for KENSEY NASH ECM SURGICAL PATCH, Substantially Equivalent on 2010-05-18. Applicant: Kensey Nash Corporation.

Clearance details

Applicant: Kensey Nash Corporation
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 2009-12-31
Decision date: 2010-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Exton, PA, US

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Adverse events under product code FTM

product code FTM

Death: 17
Injury: 2,174
Total: 2,191

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.