# K043480: Enhance Clitoral Stimulation Aid

- Pathway: 510(k) (Traditional)
- Applicant: Gynavations, Inc.
- Decided: Jun 8, 2005 after 174 days
- Product code: NBV (Device, Engorgement, Clitoral)
- Device class: 2
- Regulation: 21 CFR 884.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Enhance CSA is Indicated for women with the following symptoms of Female Sexual Dysfunction: diminished arousal (and lubrication), sexual desire and ability to achieve orgasm.

Source page: https://510kreport.com/device/K043480
Methodology: https://510kreport.com/methodology