K162201 is an FDA 510(k) clearance for the Desara TV, Desara Blue TV. 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 January 11, 2017, 159 days after receiving the submission on August 5, 2016.
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 | K162201 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2016 |
| Decision Date | January 11, 2017 |
| Days to Decision | 159 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| 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 |