Cleared Traditional

K946243 - CONVEEN SELF-SEALING URISHEATH MALE EXT...

K946243 is the FDA 510(k) clearance for CONVEEN SELF-SEALING URISHEATH MALE EXT... by Coloplast A/S. It is a Class 1 Gastroenterology & Urology device (product code EXJ) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K946243 · Coloplast A/S · Gastroenterology & Urology device
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Feb 1995
Decision
53d
Days
Class 1
Risk

K946243 is an FDA 510(k) clearance for the CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER. Classified as Device, Incontinence, Urosheath Type, Sterile (product code EXJ), Class I - General Controls.

Submitted by Coloplast A/S (Marietta, US). The FDA issued a Cleared decision on February 13, 1995 after a review of 53 days - a notably fast clearance 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: 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 Coloplast A/S devices

Submission Details

510(k) Number K946243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1994
Decision Date February 13, 1995
Days to Decision 53 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 130d · This submission: 53d
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.

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

Devices cleared under the same product code (EXJ) and FDA review panel - the closest regulatory comparables to K946243.
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