K121641 is an FDA 510(k) clearance for the MINIARC PRO SINGLE-INCISION SLING SYSTEM, a Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling (Class II — Special Controls, product code PAH), submitted by American Medical Systems (Minnetonka, US). The FDA issued a Cleared decision on September 7, 2012, 95 days after receiving the submission on June 4, 2012. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K121641 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 04, 2012 |
| Decision Date | September 07, 2012 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PAH — Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | Transvaginal Surgical Repair Of Female Stress Urinary Incontinence (sui) Due To Intrinsic Sphincter Deficiency (isd) And/or Urethral Hypermobility. |