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510(k) K080200

WATER WORKS DOUCHING DEVICE by Abbott Research Group, Inc. — Product Code HED

K080200 is an FDA 510(k) premarket notification submitted by Abbott Research Group, Inc. for the device "WATER WORKS DOUCHING DEVICE". The FDA issued a decision of Substantially Equivalent on July 10, 2008. The device falls under product code HED (Douche Apparatus, Vaginal, Therapeutic), a Class I device regulated under 21 CFR 884.5900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2008
Date Received
January 25, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Douche Apparatus, Vaginal, Therapeutic
Device Class
Class I
Regulation Number
884.5900
Review Panel
OB
Submission Type

Other clearances for product code HED

  • K030056 — WORRY-REMOVER IRRIGATOR (April 22, 2003)
  • K000736 — LA JOIE (August 8, 2000)
  • K902830 — PERI-BOTTLE (August 6, 1990)
  • K881216 — GENT-L-KARE VAGINAL IRRIGATION SET (June 7, 1988)
  • K854595 — P.A. MEDICAL VAGINAL IRRIGATION SET #1130 (January 13, 1986)
  • K841710 — MAC LEE VAGINAL IRRIGATOR (June 19, 1984)
  • K831667 — FEMININE HYGIENE DEVICE (September 12, 1983)
  • K800956 — DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN (October 3, 1980)
  • K800954 — DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID (October 3, 1980)
  • K800957 — DOUCHE UNIT-1500 ML DISP. CONTAINER (July 14, 1980)

FDA data resources