# K052175: I-Stop Mid-Urethral Sling, Models IS-1000, IS-2000, IS-3000, IS-4000

- Pathway: 510(k) (Traditional)
- Applicant: Uroplasty, Inc.
- Decided: Oct 17, 2005 after 68 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: 1 generation back to K974098 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974098: Pubouurethral Sling, ETHICON, Inc. (1998) Summary page 1.

## Most influential descendants
- K103022: KIM (2011), 0 descendants of its own

## Indications for use
The I-STOP Mid-Urethral Sling is intended for the treatment of female stress urinary incontinence (SUI) due to urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

Source page: https://510kreport.com/device/K052175
Methodology: https://510kreport.com/methodology