POLYFORM SYNTHETIC MESH— 510(k) K051245

Name: FDA 510(k) clearance K051245
Creator: U.S. Food and Drug Administration
Published: 2005-06-17

Substantially Equivalent

Proxy Biomedical , Ltd.

FDA 510(k) clearance K051245 for POLYFORM SYNTHETIC MESH, Substantially Equivalent on 2005-06-17. Applicant: Proxy Biomedical , Ltd.. Device class: 2.

Clearance details

Applicant: Proxy Biomedical , Ltd.
Product code: Code OTO
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2005-05-16
Decision date: 2005-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

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K060520 — VITAMESH MACROPOROUS PP SURGICAL MESH2006-03-28
K052100 — MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH2005-08-11
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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.