K123179 is an FDA 510(k) clearance for the AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING. 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 C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on November 2, 2012, 24 days after receiving the submission on October 9, 2012.
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 | K123179 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 2012 |
| Decision Date | November 02, 2012 |
| Days to Decision | 24 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. |