K231891 is an FDA 510(k) clearance for the Virtue Male Sling System with Alexis Wound Retractor Convenience Kit. This device is classified as a Mesh, Surgical, For Stress Urinary Incontinence, Male (Class II - Special Controls, product code OTM).
Submitted by Coloplast (Plymouth, US). The FDA issued a Cleared decision on September 25, 2023, 90 days after receiving the submission on June 27, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.3300. Surgical Treatment Of Male Stress Urinary Incontinence Post-prostatectomy.
| 510(k) Number | K231891 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | June 27, 2023 |
| Decision Date | September 25, 2023 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | OTM - Mesh, Surgical, For Stress Urinary Incontinence, Male |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | Surgical Treatment Of Male Stress Urinary Incontinence Post-prostatectomy |