Cleared Special

K023975 - VOYAGER LINUX

K023975 is an FDA 510(k) clearance for VOYAGER LINUX, manufactured by Z-Kat, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Special 510(k) pathway after a 18-day FDA review.

K023975 · Z-Kat, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
18d
Days
Class 2
Risk

K023975 is an FDA 510(k) clearance for the VOYAGER LINUX. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Z-Kat, Inc. (Hollywood, US). The FDA issued a Cleared decision on December 20, 2002 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Z-Kat, Inc. devices

FDA 510(k) Submission Details - K023975

510(k) Number K023975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2002
Decision Date December 20, 2002
Days to Decision 18 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 148d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

HAW Device Classification - Class 2, Special Controls

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 287
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K023975.
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K021798 · Smith & Nephew, Inc. · Dec 2002
VECTORVISION CT-FREE KNEE
K021306 · Brainlab AG · Oct 2002
SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS
K021815 · Smith & Nephew, Inc. · Oct 2002