Water Works Douching Device

FDA 510(k) K080200 · Abbott Research Group, Inc.

Substantially Equivalent

510(k) numberK080200

Submission

Device name
Water Works Douching Device
Applicant
Abbott Research Group, Inc.
North Attleboro, MA, US
Received
January 25, 2008
Decision date
July 10, 2008
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

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K030056Worry-Remover IrrigatorHED · Traditional Corisen Group, Ltd.04/22/2003SE
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 Water Works Douching Device cleared by the FDA?

Water Works Douching Device (K080200) received a 510(k) decision of Substantially Equivalent on July 10, 2008, 167 days after the submission was received.

What is the product code of K080200?

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