MINITAPE EXTRA URETHRAL SLING— 510(k) K073647

Substantially Equivalent

Mpathy Medical Devices, Ltd.

FDA 510(k) clearance K073647 for MINITAPE EXTRA URETHRAL SLING, Substantially Equivalent on 2008-03-03. Applicant: Mpathy Medical Devices, Ltd..

Clearance details

Applicant: Mpathy Medical Devices, Ltd.
Product code: Code OTN
Advisory panel: General, Plastic Surgery
Date received: 2007-12-26
Decision date: 2008-03-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Madison, CT, US

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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.