K113496 is an FDA 510(k) clearance for the VIRTURE 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 A/S (Plymouth, US). The FDA issued a Cleared decision on February 14, 2012, 81 days after receiving the submission on November 25, 2011.
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 | K113496 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 2011 |
| Decision Date | February 14, 2012 |
| Days to Decision | 81 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 |