DuraFuse Clip and Applier System— 510(k) K213813

Substantially Equivalent

Neuramedica, Inc.

FDA 510(k) clearance K213813 for DuraFuse Clip and Applier System, Substantially Equivalent on 2022-07-22. Applicant: Neuramedica, Inc..

Clearance details

Applicant: Neuramedica, Inc.
Product code: Code FZP
Advisory panel: General, Plastic Surgery
Date received: 2021-12-07
Decision date: 2022-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oregon City, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FZP

product code FZP

Death: 11
Injury: 726
Malfunction: 10,830
Other: 1
Total: 11,568

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.