Cleared Traditional

K923822 - AUTOLITH-IEHL

K923822 is the FDA 510(k) clearance for AUTOLITH-IEHL by Northgate Technologies, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FFK) cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K923822 · Northgate Technologies, Inc. · Gastroenterology & Urology device
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Jan 1993
Decision
182d
Days
Class 2
Risk

K923822 is an FDA 510(k) clearance for the AUTOLITH-IEHL. 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 January 28, 1993 after a review of 182 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 K923822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1992
Decision Date January 28, 1993
Days to Decision 182 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
52d slower than avg
Panel avg: 130d · This submission: 182d
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 K923822.
PULSE GUARD 3FR ELECTRODE
K944571 · Northgate Technologies, Inc. · Mar 1995
RIWOLITH 2280 PROBES
K931755 · Richard Wolf Medical Instruments Corp. · Apr 1994
PULSE GUARD ELECTRODE
K925396 · Northgate Technologies, Inc. · Jul 1993
SD-200IEHL(TM)
K914517 · Northgate Technologies, Inc. · Jun 1992
RIWOLITH 2280
K913487 · Richard Wolf Medical Instruments Corp. · Feb 1992
3 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
K914515 · Northgate Technologies, Inc. · Jan 1992