K953969

Substantially Equivalent

PRECLUDE DURA SUBSTITUTE

Applicant: W. L. Gore & Associates, Inc.
Product code: GXQ
Advisory panel: Neurology
Date received: 1995-08-22
Decision date: 1995-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

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.