K221874 is an FDA 510(k) clearance for the Altis Single Incision Sling System. 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 Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on February 15, 2023, 232 days after receiving the submission on June 28, 2022.
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 | K221874 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2022 |
| Decision Date | February 15, 2023 |
| Days to Decision | 232 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| 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. |