Cleared Traditional

K944571 - PULSE GUARD 3FR ELECTRODE

K944571 is the FDA 510(k) clearance for PULSE GUARD 3FR ELECTRODE by Northgate Technologies, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FFK) cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K944571 · Northgate Technologies, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
179d
Days
Class 2
Risk

K944571 is an FDA 510(k) clearance for the PULSE GUARD 3FR ELECTRODE. Classified as Lithotriptor, Electro-hydraulic (product code FFK), Class II - Special Controls.

Submitted by Northgate Technologies, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on March 17, 1995 after a review of 179 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4480 - 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 Northgate Technologies, Inc. devices

Submission Details

510(k) Number K944571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1994
Decision Date March 17, 1995
Days to Decision 179 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
49d slower than avg
Panel avg: 130d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FFK Lithotriptor, Electro-hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4480
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 - FFK Lithotriptor, Electro-hydraulic

All 26
Devices cleared under the same product code (FFK) and FDA review panel - the closest regulatory comparables to K944571.
ELECTRO MECHANICAL LITHOTRIPTOR
K990341 · Northgate Technologies, Inc. · Jul 1999
KSEA CALCUSPLIT
K981233 · KARL STORZ Endoscopy-America, Inc. · Jun 1998
MICROVASIVE LIPTHOTRIPSY PROBES
K973788 · Boston Scientific Corp · Jan 1998
RIWOLITH 2280 PROBES
K931755 · Richard Wolf Medical Instruments Corp. · Apr 1994
PULSE GUARD ELECTRODE
K925396 · Northgate Technologies, Inc. · Jul 1993
AUTOLITH-IEHL
K923822 · Northgate Technologies, Inc. · Jan 1993