Phasix Mesh— 510(k) K161424

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K161424 for Phasix Mesh, Substantially Equivalent on 2016-09-29. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code OOD
Advisory panel: General, Plastic Surgery
Date received: 2016-05-23
Decision date: 2016-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warwick, RI, US

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Adverse events under product code OOD

product code OOD

Death: 6
Injury: 1,005
Total: 1,011

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.