K020654 is an FDA 510(k) clearance for the STRATASIS SLING KIT. This device is classified as 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 April 9, 2002, 40 days after receiving the submission on February 28, 2002.
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 | K020654 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2002 |
| Decision Date | April 09, 2002 |
| Days to Decision | 40 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. |