MODIFICATION TO: MINIMESH POLYPROPYLENE MESH— 510(k) K053361

Name: FDA 510(k) clearance K053361
Creator: U.S. Food and Drug Administration
Published: 2006-02-06

Substantially Equivalent

Mpathy Medical Devices, Ltd.

FDA 510(k) clearance K053361 for MODIFICATION TO: MINIMESH POLYPROPYLENE MESH, Substantially Equivalent on 2006-02-06. Applicant: Mpathy Medical Devices, Ltd.. Device class: 2.

Clearance details

Applicant: Mpathy Medical Devices, Ltd.
Product code: Code OTO
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2005-12-02
Decision date: 2006-02-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Farfield, CT, US

Download summary PDF View on FDA.gov ↗

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K073647 — MINITAPE EXTRA URETHRAL SLING2008-03-03
K073646 — MINITAPE URETHRAL SLING2008-02-25
K041632 — MINIMESH POLYPROPYLENE MESH2004-11-17

Adverse events under product code OTO

product code OTO

Injury: 840
Total: 840

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.