# K082640: Virtue Ventral Urethral Elevation Sling System

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Manufacturing Us, LLC
- Decided: Oct 17, 2008 after 37 days
- Product code: OTM (Mesh, Surgical, For Stress Urinary Incontinence, Male)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K931386 (1993). 32 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053371: Ams Male Transobturator Sling System, American Medical Systems, Inc. (2006) Summary page 1.

## Most influential descendants
- K091152: Virtue Ventral Urethral Elevation Sling System, Model 50020 (2009), 4 descendants of its own
- K101297: Virtue Ventral Urethral Elevation Sling System Model 50020 (2010), 3 descendants of its own
- K113496: Virture Male Sling System with Alexis Wound Retractor Convenience Kit (2012), 1 descendant of its own
- K231891: Virtue Male Sling System with Alexis Wound Retractor Convenience Kit (2023), 0 descendants of its own
- K111881: Virtue Male Sling System and Alexis (R) Wound Retractor Kit (2011), 0 descendants of its own

## Indications for use
The Coloplast VIRTUE Ventral Urethral Elevation Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

Source page: https://510kreport.com/device/K082640
Methodology: https://510kreport.com/methodology