K090688 is an FDA 510(k) clearance for the COOK UROLOGICAL GRAFT, a Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (Class II — Special Controls, product code PAG), submitted by Cook Biotech, Inc. (West Lafayette, US). The FDA issued a Cleared decision on July 10, 2009, 116 days after receiving the submission on March 16, 2009. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K090688 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 16, 2009 |
| Decision Date | July 10, 2009 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PAG — Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| 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. |