K110420 is an FDA 510(k) clearance for the OPHIRA MINI SLING SYSTEM, a Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling (Class II — Special Controls, product code PAH), submitted by Promedon S.A (Piscataway, US). The FDA issued a Cleared decision on May 8, 2012, 449 days after receiving the submission on February 14, 2011. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K110420 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 14, 2011 |
| Decision Date | May 08, 2012 |
| Days to Decision | 449 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. |