# K222293: ArcSP Suprapubic Sling System

- Pathway: 510(k) (Special)
- Applicant: Urocure, LLC
- Decided: Sep 21, 2022 after 51 days
- Product code: OTN (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator)
- 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: 10 generations back to K011251 (2001). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183134: ArcTV Transvaginal Sling System, Urocure, LLC (2019) Summary page 5.

## Indications for use
The ArcSP Suprapubic Sling System is indicated to be placed at the mid-urethra for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

Source page: https://510kreport.com/device/K222293
Methodology: https://510kreport.com/methodology