Cleared Traditional

K940269 - HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K940269 · Hollister, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jun 1994
Decision
132d
Days
Class 1
Risk

K940269 is an FDA 510(k) clearance for the HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL 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 June 2, 1994 after a review of 132 days - within the typical 510(k) review window.

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 Hollister, Inc. devices

Submission Details

510(k) Number K940269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1994
Decision Date June 02, 1994
Days to Decision 132 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
2d slower than avg
Panel avg: 130d · This submission: 132d
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.