DURAFORM Dural Graft Implant— 510(k) K152481

Substantially Equivalent

Codman & Shurtleff, Inc.

FDA 510(k) clearance K152481 for DURAFORM Dural Graft Implant, Substantially Equivalent on 2015-10-30. Applicant: Codman & Shurtleff, Inc..

Clearance details

Applicant: Codman & Shurtleff, Inc.
Product code: Code GXQ
Advisory panel: Neurology
Date received: 2015-08-31
Decision date: 2015-10-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Raynham, MA, US

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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.