Cleared Traditional

WORRY-REMOVER IRRIGATOR (K030056) - FDA 510(k) Clearance

Class I Obstetrics & Gynecology device.

K030056 · Corisen Group, Ltd. · Obstetrics & Gynecology device
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Apr 2003
Decision
106d
Days
Class 1
Risk

K030056 is an FDA 510(k) clearance for the WORRY-REMOVER IRRIGATOR. Classified as Douche Apparatus, Vaginal, Therapeutic (product code HED), Class I - General Controls.

Submitted by Corisen Group, Ltd. (West Chester, US). The FDA issued a Cleared decision on April 22, 2003 after a review of 106 days - within the typical 510(k) review window.

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 Corisen Group, Ltd. devices

Submission Details

510(k) Number K030056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2003
Decision Date April 22, 2003
Days to Decision 106 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
54d faster than avg
Panel avg: 160d · This submission: 106d
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.