VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM— 510(k) K082640

Clearance details

Applicant

Coloplast Manufacturing Us, LLC

Product code

Code OTM

Device class

Class 2

Regulation

21 CFR 878.3300

Advisory panel

General, Plastic Surgery

Date received

2008-09-10

Decision date

2008-10-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Minneapolis, MN, US

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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 →