# K123179: Ajust Helical Adjustable Single-Incision Sling

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Nov 2, 2012 after 24 days
- Product code: PAH (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K092607 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092607: Ajust Adjustable Single Incision Sling, C.R. Bard, Inc. (2009) Summary page 1.

## Indications for use
Ajusto Helical Adjustable Single-incision Sling is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K123179
Methodology: https://510kreport.com/methodology