Cleared Traditional

K864904 - 3F ELECTRODE

K864904 is the FDA 510(k) clearance for 3F ELECTRODE by Northgate Research, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FFK) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K864904 · Northgate Research, Inc. · Gastroenterology & Urology device
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Feb 1987
Decision
57d
Days
Class 2
Risk

K864904 is an FDA 510(k) clearance for the 3F ELECTRODE. Classified as Lithotriptor, Electro-hydraulic (product code FFK), Class II - Special Controls.

Submitted by Northgate Research, Inc. (Plattsburgh, US). The FDA issued a Cleared decision on February 10, 1987 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Northgate Research, Inc. devices

Submission Details

510(k) Number K864904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1986
Decision Date February 10, 1987
Days to Decision 57 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 130d · This submission: 57d
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 31
Devices cleared under the same product code (FFK) and FDA review panel - the closest regulatory comparables to K864904.
MDL-1 LASERTRIPTER(TM)
K885255 · Candela Laser Corp. · Jun 1989
MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS
K883189 · KARL STORZ Endoscopy-America, Inc. · Feb 1989
MDL-1 LASERTRIPTER
K880503 · Candela Laser Corp. · Jun 1988
CANDELA MODEL MDL-1 LASER LITHOTRIPTOR
K863642 · Candela Corp. · Dec 1986
LITHOTRIPTOR ELECTRODE 4.5F
K834228 · Monaghan Medical Corp. · May 1984
4.5 F LITHOTRIPTOR ELECTRODE
K830086 · Monaghan Medical Corp. · Feb 1983