MESO BILAYER SURGICAL MESH— 510(k) K132025

Name: FDA 510(k) clearance K132025
Creator: U.S. Food and Drug Administration
Published: 2013-10-30

Substantially Equivalent

Kensey Nash Corporation Dba Dsm Biomedical

FDA 510(k) clearance K132025 for MESO BILAYER SURGICAL MESH, Substantially Equivalent on 2013-10-30. Applicant: Kensey Nash Corporation Dba Dsm Biomedical. Device class: 2.

Clearance details

Applicant: Kensey Nash Corporation Dba Dsm Biomedical
Product code: Code FTM
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2013-07-01
Decision date: 2013-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Exton, PA, US

Download summary PDF View on FDA.gov ↗

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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.