Cleared Traditional

K012366 - NAVIGUS II TRAJECTORY GUIDE

K012366 is an FDA 510(k) clearance for NAVIGUS II TRAJECTORY GUIDE, 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 67-day FDA review.

K012366 · Image-Guided Neurologics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
67d
Days
Class 2
Risk

K012366 is an FDA 510(k) clearance for the NAVIGUS II TRAJECTORY GUIDE. 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 October 1, 2001 after a review of 67 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 - K012366

510(k) Number K012366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2001
Decision Date October 01, 2001
Days to Decision 67 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
81d faster than avg
Panel avg: 148d · This submission: 67d
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 K012366.
MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE
K013861 · Elekta Instrument AB · Dec 2001
HEMI-ARC SURGICAL NAVIGATOR
K013257 · Nuvasive, Inc. · Oct 2001
NAVIGUS II MR
K012719 · Image-Guided Neurologics, Inc. · Oct 2001
VECTORVISION HIP
K010602 · Brainlab AG · Sep 2001
VECTORVISION KNEE
K010612 · Brainlab AG · Sep 2001
MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM
K012564 · Brainlab AG · Sep 2001