DuraGen Secure Dural Regeneration Matrix— 510(k) K163456

Substantially Equivalent

Integra LifeSciences Corporation

FDA 510(k) clearance K163456 for DuraGen Secure Dural Regeneration Matrix, Substantially Equivalent on 2017-01-06. Applicant: Integra LifeSciences Corporation.

Clearance details

Applicant: Integra LifeSciences Corporation
Product code: Code GXQ
Advisory panel: Neurology
Date received: 2016-12-09
Decision date: 2017-01-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Planisboro, NJ, US

Download summary PDF View on FDA.gov ↗

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.