Cleared Traditional

FEMASSIST URINARY DEVICE (K963858) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K963858 · Insight Medical Corp. · Gastroenterology & Urology device
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Oct 1997
Decision
391d
Days
Class 1
Risk

K963858 is an FDA 510(k) clearance for the FEMASSIST URINARY DEVICE. Classified as External Urethral Occluder, Urinary Incontinence-control, Female (product code MNG), Class I - General Controls.

Submitted by Insight Medical Corp. (Bolton, US). The FDA issued a Cleared decision on October 21, 1997 after a review of 391 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5160 - the FDA gastroenterology and urology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K963858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1996
Decision Date October 21, 1997
Days to Decision 391 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
261d slower than avg
Panel avg: 130d · This submission: 391d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MNG External Urethral Occluder, Urinary Incontinence-control, Female
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5160
Definition Intended To Prevent Or Decrease Episodes Of Urine Leakage In Women With Stress Incontinence. Occluder Is Applied To Urinary Meatus Through Suction Or Tape, Which Creates A Barrier For Urine Leakage. Occluding Device Such As A Cap, Suction Cup, Or Foam Pad. May Include Adhesive Gel Or Ointment.
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.