# K063079: I-Stop Trans Obturator Male Sling

- Pathway: 510(k) (Traditional)
- Applicant: Cl Medical
- Decided: Nov 7, 2006 after 28 days
- Product code: OTM (Mesh, Surgical, For Stress Urinary Incontinence, Male)
- 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 K931386 (1993). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051533: I-STOP, Cl Medical (2005) Summary page 1.
- K053371: Ams Male Transobturator Sling System, American Medical Systems, Inc. (2006) Summary page 1.

## Indications for use
I-STOP ® Trans Obturator Male / Female Sling is intended to be used as a sub-urethral sling implant for the treatment of male stress urinary incontinence post-prostatectomy. And for females: for the treatment of urinary stress incontinence due to intrinsic sphincter deficiency and/or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K063079
Methodology: https://510kreport.com/methodology