Worry-Remover Irrigator

FDA 510(k) K030056 · Corisen Group, Ltd.

Substantially Equivalent

510(k) numberK030056

Submission

Device name
Worry-Remover Irrigator
Applicant
Corisen Group, Ltd.
West Chester, OH, US
Received
January 6, 2003
Decision date
April 22, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HED – Douche Apparatus, Vaginal, Therapeutic
Device class
Class I (low risk)
Regulation
21 CFR 884.5900
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HED

510(k)DeviceApplicantDecision
K080200Water Works Douching DeviceHED · Traditional Abbott Research Group, Inc.07/10/2008SE
K000736La JoieHED · Traditional Goomi Ehwa, Inc.08/08/2000SE
K902830Peri-BottleHED · Traditional Orion Life Systems, Inc.08/06/1990SE
K881216Gent-L-Kare Vaginal Irrigation SetHED · Traditional Geneva Laboratories, Inc.06/07/1988SE
K854595P.A. Medical Vaginal Irrigation Set #1130HED · Traditional Pa Medical Corp.01/13/1986SE
K841710Mac Lee Vaginal IrrigatorHED · Traditional Mac Lee Medical Products06/19/1984SE
K831667Feminine Hygiene DeviceHED · Traditional Snow Willow Co.09/12/1983SE
K800956Douch Tray-Disposable Vaginal Tray W/BenHED · Traditional The Healthcare Group Laboratories, Inc.10/03/1980SE
K800954Douche Tray-Dispos. Vaginal Tray W/PovidHED · Traditional The Healthcare Group Laboratories, Inc.10/03/1980SE
K800957Douche UNIT-1500 ML Disp. ContainerHED · Traditional The Healthcare Group Laboratories, Inc.07/14/1980SE

Questions and answers

When was Worry-Remover Irrigator cleared by the FDA?

Worry-Remover Irrigator (K030056) received a 510(k) decision of Substantially Equivalent on April 22, 2003, 106 days after the submission was received.

What is the product code of K030056?

The FDA product code is HED – Douche Apparatus, Vaginal, Therapeutic, a Class I (low risk) device regulated under 21 CFR 884.5900.