K121928 is an FDA 510(k) clearance for the DESARA SL. This device is classified as a Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (Class II - Special Controls, product code OTN).
Submitted by Caldera Medical, Inc. (Agoura Hills, US). The FDA issued a Cleared decision on February 19, 2013, 232 days after receiving the submission on July 2, 2012.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.3300. Surgical Treatment Of Female Stress Urinary Incontinence Due To Intrinsic Sphincter Deficiency (isd) And/or Urethral Hypermobility.
| 510(k) Number | K121928 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2012 |
| Decision Date | February 19, 2013 |
| Days to Decision | 232 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | OTN — Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | Surgical Treatment Of Female Stress Urinary Incontinence Due To Intrinsic Sphincter Deficiency (isd) And/or Urethral Hypermobility |