Cleared Traditional

K080200 - WATER WORKS DOUCHING DEVICE (FDA 510(k) Clearance)

Class I Obstetrics & Gynecology device.

K080200 · Abbott Research Group, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
167d
Days
Class 1
Risk

K080200 is an FDA 510(k) clearance for the WATER WORKS DOUCHING DEVICE. Classified as Douche Apparatus, Vaginal, Therapeutic (product code HED), Class I - General Controls.

Submitted by Abbott Research Group, Inc. (North Attleboro, US). The FDA issued a Cleared decision on July 10, 2008 after a review of 167 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5900 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Research Group, Inc. devices

Submission Details

510(k) Number K080200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2008
Decision Date July 10, 2008
Days to Decision 167 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 160d · This submission: 167d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HED Douche Apparatus, Vaginal, Therapeutic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.5900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.