K211223 is an FDA 510(k) clearance for the Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System. 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 Boston Scientific Corporation (Malborough, US). The FDA issued a Cleared decision on July 21, 2021, 89 days after receiving the submission on April 23, 2021.
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 | K211223 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 2021 |
| Decision Date | July 21, 2021 |
| Days to Decision | 89 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 |