MINITAPE URETHRAL SLING— 510(k) K091180

Substantially Equivalent

Mpathy Medical Devices, Ltd.

FDA 510(k) clearance K091180 for MINITAPE URETHRAL SLING, Substantially Equivalent on 2009-07-14. Applicant: Mpathy Medical Devices, Ltd..

Clearance details

Applicant: Mpathy Medical Devices, Ltd.
Product code: Code PAH
Advisory panel: General, Plastic Surgery
Date received: 2009-04-23
Decision date: 2009-07-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Glasgow, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code PAH

product code PAH

Injury: 886
Malfunction: 529
Total: 1,415

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.