K211847 is an FDA 510(k) clearance for the AdVance XP Male Sling System. This device is classified as a Mesh, Surgical, For Stress Urinary Incontinence, Male (Class II - Special Controls, product code OTM).
Submitted by Boston Scientific Corporation (Marborough, US). The FDA issued a Cleared decision on December 20, 2021, 188 days after receiving the submission on June 15, 2021.
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 | K211847 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2021 |
| Decision Date | December 20, 2021 |
| Days to Decision | 188 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 |