Cleared Traditional

NORTHGATE FLOW ASSIST TUBING FOR UROLOGY (K943361) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K943361 · Northgate Technologies, Inc. · Gastroenterology & Urology device
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Sep 1995
Decision
443d
Days
Class 2
Risk

K943361 is an FDA 510(k) clearance for the NORTHGATE FLOW ASSIST TUBING FOR UROLOGY. Classified as System, Irrigation, Urological (product code LJH), Class II - Special Controls.

Submitted by Northgate Technologies, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on September 29, 1995 after a review of 443 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Northgate Technologies, Inc. devices

Submission Details

510(k) Number K943361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1994
Decision Date September 29, 1995
Days to Decision 443 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
313d slower than avg
Panel avg: 130d · This submission: 443d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJH System, Irrigation, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - LJH System, Irrigation, Urological

All 27
Devices cleared under the same product code (LJH) and FDA review panel - the closest regulatory comparables to K943361.
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K970946 · Medline Industries, Inc. · Jun 1997
TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS
K960787 · Baxter Healthcare Corp · May 1996
KSEA DISPOSABLE TUBING SET FOR THE UROMAT PUMP
K945210 · KARL STORZ Endoscopy-America, Inc. · Feb 1995