Cleared Traditional

K944378 - ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K944378 · Regulatory & Marketing Services, Inc. · Gastroenterology & Urology device
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Feb 1995
Decision
161d
Days
Class 1
Risk

K944378 is an FDA 510(k) clearance for the ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG. Classified as Probe And Director, Gastro-urology (product code FGM), Class I - General Controls.

Submitted by Regulatory & Marketing Services, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on February 15, 1995 after a review of 161 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4730 - 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.

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Submission Details

510(k) Number K944378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1994
Decision Date February 15, 1995
Days to Decision 161 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
31d slower than avg
Panel avg: 130d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FGM Probe And Director, Gastro-urology
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4730
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.