# K051533: I-STOP

- Pathway: 510(k) (Traditional)
- Applicant: Cl Medical
- Decided: Aug 11, 2005 after 63 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: 5 generations back to K011251 (2001). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012628: Gynecare Tension-Free Vaginal Tape System, Gynecare Center (2001) Summary page 1.
- K013355: Sparc Sling System, American Medical Systems, Inc. (2001) Summary page 1.
- K023516: Monarc Sling System, American Medical Systems, Inc. (2002) Summary page 1.
- K033568: Gynecare TVT Obturator System, ETHICON, Inc. (2003) Summary page 1.
- K041176: Uretex to Trans-Obturator Urethral Support System, Sofradim Production (2004) Summary page 1.
- K050148: Mentor Aris Trans-Obturator Tape and Surgical Kit, Mentor Corporation (2005) Summary page 1.

## Most influential descendants
- K063079: I-Stop Trans Obturator Male Sling (2006), 0 descendants of its own

## Indications for use
I-STOP® is intended to be used as a pubo-urethral sling for the treatment of female urinary incontinence.

Source page: https://510kreport.com/device/K051533
Methodology: https://510kreport.com/methodology