BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT— 510(k) K131015

Name: FDA 510(k) clearance K131015
Creator: U.S. Food and Drug Administration
Published: 2013-10-08

Substantially Equivalent

Cook Biotech, Inc.

FDA 510(k) clearance K131015 for BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT, Substantially Equivalent on 2013-10-08. Applicant: Cook Biotech, Inc.. Device class: 2.

Clearance details

Applicant: Cook Biotech, Inc.
Product code: Code GXQ
Device class: Class 2
Regulation: 21 CFR 882.5910
Advisory panel: Neurology
Date received: 2013-04-11
Decision date: 2013-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Lafayette, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GXQ

product code GXQ

Death: 11
Injury: 446
Other: 1
Total: 458

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.