# K080200: Water Works Douching Device

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Research Group, Inc.
- Decided: Jul 10, 2008 after 167 days
- Product code: HED (Douche Apparatus, Vaginal, Therapeutic)
- Device class: 1
- Regulation: 21 CFR 884.5900
- 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. The FDA summary names its predicate without a number.
- (no number) Good Health Premium Fountain Style Personal Douche and Enema System: named in the summary without a submission number

## Indications for use
The WaterWorks® Douching Device is indicated for the reduction or abatement of perceived vaginal odor with or without complaints of discharge in women with no infectious cause of vaginitis.

Source page: https://510kreport.com/device/K080200
Methodology: https://510kreport.com/methodology