Cleared Traditional

K943361 - NORTHGATE FLOW ASSIST TUBING FOR UROLOGY

K943361 is an FDA 510(k) clearance for NORTHGATE FLOW ASSIST TUBING FOR UROLOGY, manufactured by Northgate Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LJH cleared through the Traditional 510(k) pathway after a 443-day FDA review.

K943361 · Northgate Technologies, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K943361

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
312d slower than avg
Panel avg: 131d · This submission: 443d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJH Device Classification - Class 2, Special Controls

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 14
Devices cleared under the same product code (LJH) and FDA review panel - the closest regulatory comparables to K943361.
MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET
K970946 · Medline Industries, Inc. · Jun 1997
NHMC IRRIGATION TRAY
K962670 · National Healthcare Mfg. Corp. · Aug 1996
TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS
K960787 · Baxter Healthcare Corp · May 1996
URO-FLO
K945140 · Mallinckrodt Group, Inc. · Mar 1995
KSEA DISPOSABLE TUBING SET FOR THE UROMAT PUMP
K945210 · KARL STORZ Endoscopy-America, Inc. · Feb 1995
THE KARL STORZ UROMAT(TM)
K940983 · KARL STORZ Endoscopy-America, Inc. · Sep 1994