Cleared Traditional

K033619 - NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM

K033619 is an FDA 510(k) clearance for NAVIGUS UNIBODY 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 105-day FDA review.

K033619 · Image-Guided Neurologics, Inc. · Neurology device
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Mar 2004
Decision
105d
Days
Class 2
Risk

K033619 is an FDA 510(k) clearance for the NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000. 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 2, 2004 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 Image-Guided Neurologics, Inc. devices

FDA 510(k) Submission Details - K033619

510(k) Number K033619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2003
Decision Date March 02, 2004
Days to Decision 105 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
43d faster than avg
Panel avg: 148d · This submission: 105d
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 K033619.
ACUMEN SURGICAL NAVIGATION SYSTEM
K031454 · Biomet, Inc. · Jul 2004
NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000
K040834 · Image-Guided Neurologics, Inc. · Jun 2004
NAVIPRO KNEE SOFTWARE MODULE
K033668 · Kinamed, Inc. · Mar 2004
ZIMMER ORTHO GUIDANCE SYSTEMS- HIP INSTRUMENTS
K033223 · Zimmer, Inc. · Feb 2004
VECTORVISION CRANIAL/ENT
K023651 · Brainlab AG · Feb 2004
ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS
K033011 · Zimmer, Inc. · Feb 2004