Cleared Traditional

CONQUEST MALE CONTINENCE SYSTEM (K942941) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K942941 · Convatec, A Bristol-Myers Squibb Co. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 1995
Decision
268d
Days
Class 1
Risk

K942941 is an FDA 510(k) clearance for the CONQUEST MALE CONTINENCE SYSTEM. Classified as Device, Incontinence, Urosheath Type, Sterile (product code EXJ), Class I - General Controls.

Submitted by Convatec, A Bristol-Myers Squibb Co. (Princeton, US). The FDA issued a Cleared decision on March 17, 1995 after a review of 268 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5250 - 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. Standard predicate reliance. 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.

View all Convatec, A Bristol-Myers Squibb Co. devices

Submission Details

510(k) Number K942941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1994
Decision Date March 17, 1995
Days to Decision 268 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
138d slower than avg
Panel avg: 130d · This submission: 268d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EXJ Device, Incontinence, Urosheath Type, Sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5250
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.