K052401 is an FDA 510(k) clearance for the GYNECARE TVT SECUR SYSTEM. This device is classified as a Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling (Class II - Special Controls, product code PAH).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on November 28, 2005, 88 days after receiving the submission on September 1, 2005.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.3300. Transvaginal Surgical Repair Of Female Stress Urinary Incontinence (sui) Due To Intrinsic Sphincter Deficiency (isd) And/or Urethral Hypermobility..
| 510(k) Number | K052401 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 2005 |
| Decision Date | November 28, 2005 |
| Days to Decision | 88 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. |