# K974645: Femassist Flexible

- Pathway: 510(k) (Traditional)
- Applicant: Insight Medical Corp.
- Decided: Feb 12, 1998 after 62 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 K963858 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963858: Femassist Urinary Device, Insight Medical Corp. (1997) Summary page 1.

## Indications for use
The INSIGHT Medical FemAssist™ Flexible is an external female continence device indicated for the management of urinary leakage in women suffering from stress urinary incontinence (SUI).

Source page: https://510kreport.com/device/K974645
Methodology: https://510kreport.com/methodology