VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020— 510(k) K091152

Name: FDA 510(k) clearance K091152
Creator: U.S. Food and Drug Administration
Published: 2009-05-07

Substantially Equivalent

Coloplast A/S

FDA 510(k) clearance K091152 for VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020, Substantially Equivalent on 2009-05-07. Applicant: Coloplast A/S. Device class: 2.

Clearance details

Applicant: Coloplast A/S
Product code: Code OTM
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2009-04-20
Decision date: 2009-05-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Humlebaek, DK

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OTM

product code OTM

Injury: 760
Total: 760

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.