OMNISURE URETHRAL SLING, MODEL OTK52— 510(k) K092203

Substantially Equivalent

Mpathy Medical Devices, Ltd.

FDA 510(k) clearance K092203 for OMNISURE URETHRAL SLING, MODEL OTK52, Substantially Equivalent on 2009-08-12. Applicant: Mpathy Medical Devices, Ltd..

Clearance details

Applicant: Mpathy Medical Devices, Ltd.
Product code: Code OTN
Advisory panel: General, Plastic Surgery
Date received: 2009-07-22
Decision date: 2009-08-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Glasgow, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code OTN

product code OTN

Injury: 6,630
Total: 6,630

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.