K111881 is an FDA 510(k) clearance for the VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR 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 August 17, 2011, 47 days after receiving the submission on July 1, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.3300. Surgical Treatment Of Male Stress Urinary Incontinence Post-prostatectomy.
| 510(k) Number | K111881 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2011 |
| Decision Date | August 17, 2011 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| 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 |