Product code HED— Obstetrics/Gynecology
DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN
- Classification name
- Douche Apparatus, Vaginal, Therapeutic
- Device class
- Class 1
- Regulation
- 21 CFR 884.5900
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 12
- First cleared
- Most recent
Market context for product code HED
FDA has cleared devices under product code HED between 1978 and 2008, filed by 10 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2008
- 2003
- 2000
- 1990
- 1988
- 1986
- 1984
- 1983
- 1980
- 1978
Top applicants under product code HED
Recent clearances under product code HED
- K080200 — WATER WORKS DOUCHING DEVICE
- K030056 — WORRY-REMOVER IRRIGATOR
- K000736 — LA JOIE
- K902830 — PERI-BOTTLE
- K881216 — GENT-L-KARE VAGINAL IRRIGATION SET
- K854595 — P.A. MEDICAL VAGINAL IRRIGATION SET #1130
- K841710 — MAC LEE VAGINAL IRRIGATOR
- K831667 — FEMININE HYGIENE DEVICE
- K800954 — DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID
- K800956 — DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN
- K800957 — DOUCHE UNIT-1500 ML DISP. CONTAINER
- K781207 — DOUCHE KIT, SOMETHING PERSONAL
Data sourced from openFDA. This site is unofficial and independent of the FDA.