# K963858: Femassist Urinary Device

- Pathway: 510(k) (Traditional)
- Applicant: Insight Medical Corp.
- Decided: Oct 21, 1997 after 391 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Miniguard (Impress): named in the summary without a submission number

## Most influential descendants
- K974645: Femassist Flexible (1998), 0 descendants of its own

## Indications for use
The FemAssietTM is an external female continence device indicated for the management of urinary leakage in women suffering from stress urinary incontinence (sSuI).

Source page: https://510kreport.com/device/K963858
Methodology: https://510kreport.com/methodology