# K954215: Miniguard

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Surgical Intervention, Inc.
- Decided: May 8, 1996 after 243 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
No predicates in its family tree.
2 later devices descend 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)
- None. The FDA summary names its predicate without a number.
- (no number) Dacomed C3 Male Continence Device: named in the summary without a submission number
- (no number) Diamed External Urinary Appliance: named in the summary without a submission number
- (no number) Xtramedics Fresh 'n Fit Padette: named in the summary without a submission number

## Most influential descendants
- K974600: Uromed Patch (1998), 1 descendant of its own
- K983164: Restore (Aka RE/Stor) (1999), 0 descendants of its own

## Indications for use
The Miniguard is an external female continence device that is applied to the urinary opening 10 prevent or decrease episodes of stress incontinence. Stress incontinence occurs when intra-abdominal pressure exceeds urethral resistance as a result of physical stress such as coughing, laughing, or lifting heavy objects. The Miniguard is designed for women who expenence urine leakage under conditions of physical stress.

Source page: https://510kreport.com/device/K954215
Methodology: https://510kreport.com/methodology