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

Name: FDA 510(k) clearance K062697
Creator: U.S. Food and Drug Administration
Published: 2006-10-13

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.. Device class: 2.

Clearance details

Applicant: Cook Biotech, Inc.
Product code: Code FTL
Device class: Class 2
Regulation: 21 CFR 878.3300
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

Download summary PDF View on FDA.gov ↗

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K131015 — BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT2013-10-08
K111695 — HYBRID GRAFT2012-04-02
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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.