MENTOR NOVASILK MESH— 510(k) K053414

Substantially Equivalent

Mentor Corp.

FDA 510(k) clearance K053414 for MENTOR NOVASILK MESH, Substantially Equivalent on 2005-12-27. Applicant: Mentor Corp..

Clearance details

Applicant: Mentor Corp.
Product code: Code OTP
Advisory panel: Obstetrics/Gynecology
Date received: 2005-12-07
Decision date: 2005-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OTP

product code OTP

Injury: 1,061
Total: 1,061

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.