HED
12 FDA 510(k) clearances · Product code
106 daysmedian time to decision
163 days90th percentile
12clearances measured
FDA profile
- Official device name
- Douche Apparatus, Vaginal, Therapeutic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.5900
- Medical specialty
- Obstetrics/Gynecology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| WATER WORKS DOUCHING DEVICE (K080200) | Abbott Research Group, Inc. | 2008-07-10 |
| WORRY-REMOVER IRRIGATOR (K030056) | Corisen Group, Ltd. | 2003-04-22 |
| LA JOIE (K000736) | Goomi Ehwa, Inc. | 2000-08-08 |
| PERI-BOTTLE (K902830) | Orion Life Systems, Inc. | 1990-08-06 |
| GENT-L-KARE VAGINAL IRRIGATION SET (K881216) | Geneva Laboratories, Inc. | 1988-06-07 |
| P.A. MEDICAL VAGINAL IRRIGATION SET #1130 (K854595) | Pa Medical Corp. | 1986-01-13 |
| MAC LEE VAGINAL IRRIGATOR (K841710) | Mac Lee Medical Products | 1984-06-19 |
| FEMININE HYGIENE DEVICE (K831667) | Snow Willow Co. | 1983-09-12 |
| DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID (K800954) | The Healthcare Group Laboratories, Inc. | 1980-10-03 |
| DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN (K800956) | The Healthcare Group Laboratories, Inc. | 1980-10-03 |
| DOUCHE UNIT-1500 ML DISP. CONTAINER (K800957) | The Healthcare Group Laboratories, Inc. | 1980-07-14 |
| DOUCHE KIT, SOMETHING PERSONAL (K781207) | Chatten Drug & Chemical Co. | 1978-08-10 |
Track HED automatically
Every clearance here is in the API, with alerts when new ones post.