Cleared Traditional

K962900 - SELF RETAINING MALE EXTERNAL URINARY CATHETER (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K962900 · Hollister, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Sep 1996
Decision
53d
Days
Class 1
Risk

K962900 is an FDA 510(k) clearance for the SELF RETAINING MALE EXTERNAL URINARY CATHETER. Classified as Device, Incontinence, Urosheath Type, Sterile (product code EXJ), Class I - General Controls.

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on September 16, 1996 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 Hollister, Inc. devices

Submission Details

510(k) Number K962900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1996
Decision Date September 16, 1996
Days to Decision 53 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
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.