HED · Class I · 21 CFR 884.5900

FDA Product Code HED: Douche Apparatus, Vaginal, Therapeutic

Leading manufacturers include The Healthcare Group Laboratories, Inc., Goomi Ehwa, Inc. and Corisen Group, Ltd..

12
Total
12
Cleared
100d
Avg days
1978
Since

FDA 510(k) Cleared Douche Apparatus, Vaginal, Therapeutic Devices (Product Code HED)

12 devices
1–12 of 12
Cleared Jul 10, 2008
WATER WORKS DOUCHING DEVICE
K080200
Abbott Research Group, Inc.
Obstetrics & Gynecology · 167d
Cleared Apr 22, 2003
WORRY-REMOVER IRRIGATOR
K030056
Corisen Group, Ltd.
Obstetrics & Gynecology · 106d
Cleared Aug 08, 2000
LA JOIE
K000736
Goomi Ehwa, Inc.
Obstetrics & Gynecology · 154d
Cleared Aug 06, 1990
PERI-BOTTLE
K902830
Orion Life Systems, Inc.
Obstetrics & Gynecology · 39d
Cleared Jun 07, 1988
GENT-L-KARE VAGINAL IRRIGATION SET
K881216
Geneva Laboratories, Inc.
Obstetrics & Gynecology · 77d
Cleared Jan 13, 1986
P.A. MEDICAL VAGINAL IRRIGATION SET #1130
K854595
Pa Medical Corp.
Obstetrics & Gynecology · 56d
Cleared Jun 19, 1984
MAC LEE VAGINAL IRRIGATOR
K841710
Mac Lee Medical Products
Obstetrics & Gynecology · 56d
Cleared Sep 12, 1983
FEMININE HYGIENE DEVICE
K831667
Snow Willow Co.
Obstetrics & Gynecology · 112d
Cleared Oct 03, 1980
DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID
K800954
The Healthcare Group Laboratories, Inc.
Obstetrics & Gynecology · 163d
Cleared Oct 03, 1980
DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN
K800956
The Healthcare Group Laboratories, Inc.
Obstetrics & Gynecology · 163d
Cleared Jul 14, 1980
DOUCHE UNIT-1500 ML DISP. CONTAINER
K800957
The Healthcare Group Laboratories, Inc.
Obstetrics & Gynecology · 82d
Cleared Aug 10, 1978
DOUCHE KIT, SOMETHING PERSONAL
K781207
Chatten Drug & Chemical Co.
Obstetrics & Gynecology · 27d

About Product Code HED - Regulatory Context