Cleared Traditional

K942941 - CONQUEST MALE CONTINENCE SYSTEM

K942941 is an FDA 510(k) clearance for CONQUEST MALE CONTINENCE SYSTEM, manufactured by Convatec, A Bristol-Myers Squibb Co.. The device is a Class 1 Gastroenterology & Urology device with product code EXJ cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K942941 · Convatec, A Bristol-Myers Squibb Co. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K942941

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.

EXJ Device Classification - Class 1, General Controls

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.

Regulatory Peers - EXJ Device, Incontinence, Urosheath Type, Sterile

All 10
Devices cleared under the same product code (EXJ) and FDA review panel - the closest regulatory comparables to K942941.
CLEAR ADVANTAGE II
K945628 · Mentor Corp. · Jul 1995
PROSYS URIHESIVE SYSTEM LA
K951530 · Convatec, A Division of E.R. Squibb & Sons · May 1995
PROSYS URIHESICE SYSTEM NL
K950690 · Convatec, A Division of E.R. Squibb & Sons · Mar 1995
CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER
K946243 · Coloplast A/S · Feb 1995
HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER
K940269 · Hollister, Inc. · Jun 1994
CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH
K924407 · Coloplast A/S · Sep 1992