Douche Apparatus, Vaginal, Therapeutic
The Therapeutic Vaginal Douche Apparatus is a device used to irrigate the vaginal canal with water or medicated solutions for therapeutic purposes. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from the 510(k) premarket notification requirement. The product code is HED, regulated under 21 CFR 884.5900, within the Obstetrics/Gynecology specialty. No special risk flags apply to this device.
Research product code HED in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- HED
- Device Class
- FDA class 1
- Regulation Number
- 884.5900
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K080200 | WATER WORKS DOUCHING DEVICE | Jul 10, 2008 | Substantially Equivalent | Abbott Research Group, Inc. |
| K030056 | WORRY-REMOVER IRRIGATOR | Apr 22, 2003 | Substantially Equivalent | Corisen Group, Ltd. |
| K000736 | LA JOIE | Aug 08, 2000 | Substantially Equivalent | Goomi Ehwa, Inc. |
| K902830 | PERI-BOTTLE | Aug 06, 1990 | Substantially Equivalent | Orion Life Systems, Inc. |
| K881216 | GENT-L-KARE VAGINAL IRRIGATION SET | Jun 07, 1988 | Substantially Equivalent | Geneva Laboratories, Inc. |
| K854595 | P.A. MEDICAL VAGINAL IRRIGATION SET #1130 | Jan 13, 1986 | Substantially Equivalent | Pa Medical Corp. |
| K841710 | MAC LEE VAGINAL IRRIGATOR | Jun 19, 1984 | Substantially Equivalent | Mac Lee Medical Products |
| K831667 | FEMININE HYGIENE DEVICE | Sep 12, 1983 | Substantially Equivalent | Snow Willow Co. |
| K800956 | DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN | Oct 03, 1980 | Substantially Equivalent | The Healthcare Group Laboratories, Inc. |
| K800954 | DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID | Oct 03, 1980 | Substantially Equivalent | The Healthcare Group Laboratories, Inc. |
| K800957 | DOUCHE UNIT-1500 ML DISP. CONTAINER | Jul 14, 1980 | Substantially Equivalent | The Healthcare Group Laboratories, Inc. |
| K781207 | DOUCHE KIT, SOMETHING PERSONAL | Aug 10, 1978 | Substantially Equivalent | Chatten Drug & Chemical Co. |
FEI Numbers
This FDA classification entry is associated with 44 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 44 registration numbers. Click on an entry to view related FDA registrations.