ALYTE Y-MESH GRAFT— 510(k) K101722

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K101722 for ALYTE Y-MESH GRAFT, Substantially Equivalent on 2011-04-01. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code OTO
Advisory panel: General, Plastic Surgery
Date received: 2010-06-18
Decision date: 2011-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Covington, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OTO

product code OTO

Injury: 840
Total: 840

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.