# K974600: Uromed Patch

- Pathway: 510(k) (Traditional)
- Applicant: Uromed Corp.
- Decided: Mar 31, 1998 after 112 days
- Product code: MNG (External Urethral Occluder, Urinary Incontinence-Control, Female)
- Device class: 1
- Regulation: 21 CFR 876.5160
- 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 K954215 (1996). 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)
- K954215: Miniguard, Advanced Surgical Intervention, Inc. (1996) Summary page 1.

## Most influential descendants
- K983164: Restore (Aka RE/Stor) (1999), 0 descendants of its own

## Indications for use
The UroMed Patch is indicated for the prevention or decrease of episodes of urine leakage in women with stress urinary incontinence.

Source page: https://510kreport.com/device/K974600
Methodology: https://510kreport.com/methodology