DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE— 510(k) K040888

Name: FDA 510(k) clearance K040888
Creator: U.S. Food and Drug Administration
Published: 2004-12-01

Substantially Equivalent

Collagen Matrix, Inc.

FDA 510(k) clearance K040888 for DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE, Substantially Equivalent on 2004-12-01. Applicant: Collagen Matrix, Inc.. Device class: 2.

Clearance details

Applicant: Collagen Matrix, Inc.
Product code: Code GXQ
Device class: Class 2
Regulation: 21 CFR 882.5910
Advisory panel: Neurology
Date received: 2004-04-05
Decision date: 2004-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, 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.