Cleared Traditional

K800956 - DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN (FDA 510(k) Clearance)

Class I Obstetrics & Gynecology device.

K800956 · The Healthcare Group Laboratories, Inc. · Obstetrics & Gynecology device
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Oct 1980
Decision
163d
Days
Class 1
Risk

K800956 is an FDA 510(k) clearance for the DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN. Classified as Douche Apparatus, Vaginal, Therapeutic (product code HED), Class I - General Controls.

Submitted by The Healthcare Group Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 3, 1980 after a review of 163 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.

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Submission Details

510(k) Number K800956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1980
Decision Date October 03, 1980
Days to Decision 163 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 160d · This submission: 163d
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.