Cleared Traditional

K854475 - GHAJAR INTRAVENTRICULAR CATHETER GUIDE

K854475 is the FDA 510(k) clearance for GHAJAR INTRAVENTRICULAR CATHETER GUIDE by Sparta Instrument Corp.. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K854475 · Sparta Instrument Corp. · Neurology device
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Feb 1986
Decision
105d
Days
Class 2
Risk

K854475 is an FDA 510(k) clearance for the GHAJAR INTRAVENTRICULAR CATHETER GUIDE. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Sparta Instrument Corp. (Chicago, US). The FDA issued a Cleared decision on February 20, 1986 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sparta Instrument Corp. devices

Submission Details

510(k) Number K854475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1985
Decision Date February 20, 1986
Days to Decision 105 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 148d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 Neurology devices follow this clearance model.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 226
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K854475.
COOK STEREOTAXIC GUIDE
K900200 · Cook, Inc. · May 1990
TARGET PROGRAM & EPSON HX-20 COMPUTER
K872877 · Walter Lorenz Surgical, Inc. · Feb 1988
KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES
K861629 · Downs Surgical , Ltd. · Aug 1986
DIASONICS, BERGER STEREOTACTIC NEOROBIOPSY
K851973 · Diasonics, Inc. · Jul 1985
MENISCECTOMY TRAY #9715
K823424 · Concept, Inc. · Mar 1983