Cleared Traditional

FEMASSIST FLEXIBLE (K974645) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K974645 · Insight Medical Corp. · Gastroenterology & Urology device
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Feb 1998
Decision
62d
Days
Class 1
Risk

K974645 is an FDA 510(k) clearance for the FEMASSIST FLEXIBLE. 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 February 12, 1998 after a review of 62 days - a notably fast clearance cycle.

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: 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 Insight Medical Corp. devices

Submission Details

510(k) Number K974645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1997
Decision Date February 12, 1998
Days to Decision 62 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
68d faster than avg
Panel avg: 130d · This submission: 62d
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.