RESTORELLE POLYPROPYLENE MESH— 510(k) K092207

Substantially Equivalent

Mpathy Medical Devices, Inc.

FDA 510(k) clearance K092207 for RESTORELLE POLYPROPYLENE MESH, Substantially Equivalent on 2009-08-04. Applicant: Mpathy Medical Devices, Inc..

Clearance details

Applicant: Mpathy Medical Devices, Inc.
Product code: Code OTP
Advisory panel: Obstetrics/Gynecology
Date received: 2009-07-22
Decision date: 2009-08-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Glasgow, GB

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.