K132655 is an FDA 510(k) clearance for the RETROARC RETROPUBIC SLING SYSTEM, a Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (Class II — Special Controls, product code OTN), submitted by American Medical Systems, Inc. (Minnetonka, US). The FDA issued a Cleared decision on November 20, 2013, 86 days after receiving the submission on August 26, 2013. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K132655 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 26, 2013 |
| Decision Date | November 20, 2013 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | OTN — Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | Surgical Treatment Of Female Stress Urinary Incontinence Due To Intrinsic Sphincter Deficiency (isd) And/or Urethral Hypermobility |