K191416 is an FDA 510(k) clearance for the Desara One Single Incision Sling System, 1 Pack. 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 Caldera Medical, Inc. (Agoura Hills, US). The FDA issued a Cleared decision on February 7, 2020, 255 days after receiving the submission on May 28, 2019.
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 | K191416 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 28, 2019 |
| Decision Date | February 07, 2020 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| 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. |