Biodesign Parastomal Hernia Repair Graft— 510(k) K162934

Substantially Equivalent

Cook Biotech Incorporated

FDA 510(k) clearance K162934 for Biodesign Parastomal Hernia Repair Graft, Substantially Equivalent on 2017-07-10. Applicant: Cook Biotech Incorporated.

Clearance details

Applicant: Cook Biotech Incorporated
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 2016-10-20
Decision date: 2017-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Lafayette, IN, US

Download summary PDF View on FDA.gov ↗

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.