Cleared Traditional

NAVIGUS II TRAJECTORY GUIDE (K012366) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K012366 · Image-Guided Neurologics, Inc. · Neurology device
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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

Submission Details

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
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.

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 104
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K012366.
ENDOMAP
K014113 · Siemens Medical Solutions USA, Inc. · Jun 2002
ORTHOPILOT 2
K013569 · Aesculap, Inc. · Apr 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS
K012938 · Smith & Nephew, Inc. · Feb 2002
VOYAGER 6.0 SOFTWARE OPTION
K000310 · Philips Medical Systems (Cleveland), Inc. · Feb 2000
VIEWPOINT ENT/ORTHOPEDIC OPTION
K991256 · Philips Medical Systems (Cleveland), Inc. · Oct 1999
VIEWPOINT TOOLS- STERRAD
K983764 · Philips Medical Systems (Cleveland), Inc. · Jul 1999