Cleared Traditional

K024201 - NAVIGUS FIDUCIAL MARKER SYSTEM

K024201 is an FDA 510(k) clearance for NAVIGUS FIDUCIAL MARKER SYSTEM, manufactured by Image-Guided Neurologics, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K024201 · Image-Guided Neurologics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
82d
Days
Class 2
Risk

K024201 is an FDA 510(k) clearance for the NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Image-Guided Neurologics, Inc. (Melbourne, US). The FDA issued a Cleared decision on March 12, 2003 after a review of 82 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. 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 Image-Guided Neurologics, Inc. devices

FDA 510(k) Submission Details - K024201

510(k) Number K024201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2002
Decision Date March 12, 2003
Days to Decision 82 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 148d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 258
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K024201.
ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT
K031999 · Elekta Instrument AB · Jul 2003
VECTORVISION FLUORO3D
K024192 · Brainlab AG · Jun 2003
DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE
K030343 · Gyrus Ent LLC · May 2003
NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES
K023949 · Image-Guided Neurologics, Inc. · Feb 2003
STRYKER NAVIGATION SYSTEM - HIP MODULE
K022365 · Stryker Instruments · Jan 2003
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
K021798 · Smith & Nephew, Inc. · Dec 2002