HED · Douche Apparatus, Vaginal, Therapeutic
Obstetrics/Gynecology · 21 CFR 884.5900 · Class 1
Overview
| Product Code | HED |
|---|---|
| Device Name | Douche Apparatus, Vaginal, Therapeutic |
| Regulation | 21 CFR 884.5900 |
| Device Class | Class 1 |
| Review Panel | Obstetrics/Gynecology |
Identification
A therapeutic vaginal douche apparatus is a device that is a bag or bottle with tubing and a nozzle. The apparatus does not include douche solutions. The apparatus is intended and labeled for use in the treatment of medical conditions except it is not for contraceptive use. After filling the therapeutic vaginal douche apparatus with a solution, the patient uses the device to direct a stream of solution into the vaginal cavity.
Classification Rationale
(1) Class II (performance standards).(2) Class I if the device is operated by gravity feed. Devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K080200 | WATER WORKS DOUCHING DEVICE | Abbott Research Group, Inc. | Jul 10, 2008 | SESE |
| K030056 | WORRY-REMOVER IRRIGATOR | Corisen Group, Ltd. | Apr 22, 2003 | SESE |
| K000736 | LA JOIE | Goomi Ehwa, Inc. | Aug 8, 2000 | SESE |
| K902830 | PERI-BOTTLE | Orion Life Systems, Inc. | Aug 6, 1990 | SESE |
| K881216 | GENT-L-KARE VAGINAL IRRIGATION SET | Geneva Laboratories, Inc. | Jun 7, 1988 | SESE |
| K854595 | P.A. MEDICAL VAGINAL IRRIGATION SET #1130 | Pa Medical Corp. | Jan 13, 1986 | SESE |
| K841710 | MAC LEE VAGINAL IRRIGATOR | Mac Lee Medical Products | Jun 19, 1984 | SESE |
| K831667 | FEMININE HYGIENE DEVICE | Snow Willow Co. | Sep 12, 1983 | SESE |
| K800956 | DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN | The Healthcare Group Laboratories, Inc. | Oct 3, 1980 | SESE |
| K800954 | DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID | The Healthcare Group Laboratories, Inc. | Oct 3, 1980 | SESE |
| K800957 | DOUCHE UNIT-1500 ML DISP. CONTAINER | The Healthcare Group Laboratories, Inc. | Jul 14, 1980 | SESE |
| K781207 | DOUCHE KIT, SOMETHING PERSONAL | Chatten Drug & Chemical Co. | Aug 10, 1978 | SESE |
Top Applicants
- The Healthcare Group Laboratories, Inc. — 3 clearances
- Abbott Research Group, Inc. — 1 clearance
- Chatten Drug & Chemical Co. — 1 clearance
- Corisen Group, Ltd. — 1 clearance
- Geneva Laboratories, Inc. — 1 clearance
