510(k) K082640
K082640 is an FDA 510(k) premarket notification submitted by Coloplast Manufacturing Us, LLC for the device "VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM". The FDA issued a decision of Substantially Equivalent on October 17, 2008. The device falls under product code OTM (Mesh, Surgical, For Stress Urinary Incontinence, Male), a Class II device regulated under 21 CFR 878.3300. Coloplast Manufacturing Us, LLC has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 2008
- Date Received
- September 10, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, For Stress Urinary Incontinence, Male
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- GU
- Submission Type
surgical treatment of male stress urinary incontinence post-prostatectomy