Cleared Traditional

GENT-L-KARE VAGINAL IRRIGATION SET (K881216) - FDA 510(k) Clearance

Class I Obstetrics & Gynecology device.

K881216 · Geneva Laboratories, Inc. · Obstetrics & Gynecology device
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Jun 1988
Decision
77d
Days
Class 1
Risk

K881216 is an FDA 510(k) clearance for the GENT-L-KARE VAGINAL IRRIGATION SET. Classified as Douche Apparatus, Vaginal, Therapeutic (product code HED), Class I - General Controls.

Submitted by Geneva Laboratories, Inc. (Elkhorn, US). The FDA issued a Cleared decision on June 7, 1988 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Geneva Laboratories, Inc. devices

Submission Details

510(k) Number K881216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1988
Decision Date June 07, 1988
Days to Decision 77 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
83d faster than avg
Panel avg: 160d · This submission: 77d
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.