SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT— 510(k) K062697

Substantially Equivalent

Cook Biotech, Inc.

FDA 510(k) clearance K062697 for SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT, Substantially Equivalent on 2006-10-13. Applicant: Cook Biotech, Inc..

Clearance details

Applicant: Cook Biotech, Inc.
Product code: Code FTL
Advisory panel: General, Plastic Surgery
Date received: 2006-09-11
Decision date: 2006-10-13
Decision: Substantially Equivalent
Clearance type: Special
Location: West Lafayette, IN, US

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Adverse events under product code FTL

product code FTL

Death: 317
Injury: 66,072
Malfunction: 1,273
Other: 3
Total: 67,665

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.