# MNG: External Urethral Occluder, Urinary Incontinence-Control, Female

- Device class: 1; regulation: 21 CFR 876.5160; FDA's rule: 510(k) exempt
- FDA decisions: 7
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1996: 1
- 1997: 2
- 1998: 2
- 1999: 1
- 2001: 1

## Most-cited predicates
- K971359: Restore (a.K.a. Capsure) (1997), cited by 1
- K963858: Femassist Urinary Device (1997), cited by 1
- K974600: Uromed Patch (1998), cited by 1
- K954215: Miniguard (1996), cited by 1

Source page: https://510kreport.com/product-code/MNG
Data by year (CSV): https://510kreport.com/product-code/MNG.csv