# K030056: Worry-Remover Irrigator

- Pathway: 510(k) (Traditional)
- Applicant: Corisen Group, Ltd.
- Decided: Apr 22, 2003 after 106 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
Longest line of descent: 1 generation back to K902830 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000736: LA Joie, Goomi Ehwa, Inc. (2000) Summary page 1.
- K902830: Peri-Bottle, Orion Life Systems, Inc. (1990) Summary page 1.

## Indications for use
The WORRRY-REMOVERTMIRRIGATOR is designed for use as a vaginal douche apparatus for general feminine hygiene applications.

Source page: https://510kreport.com/device/K030056
Methodology: https://510kreport.com/methodology