Cleared Traditional

K001192 - SELF ADHERING NAVIGUS GUIDE

K001192 is an FDA 510(k) clearance for SELF ADHERING NAVIGUS 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 56-day FDA review.

K001192 · Image-Guided Neurologics, Inc. · Neurology device
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Jun 2000
Decision
56d
Days
Class 2
Risk

K001192 is an FDA 510(k) clearance for the SELF ADHERING NAVIGUS 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 June 7, 2000 after a review of 56 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 - K001192

510(k) Number K001192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2000
Decision Date June 07, 2000
Days to Decision 56 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
92d faster than avg
Panel avg: 148d · This submission: 56d
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 K001192.
STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES
K003111 · Stryker Instruments · Jan 2001
STRYKER NAVIGATION SYSTEM - ENT MODULE
K002732 · Stryker Corp. · Oct 2000
OPTICAL TRACKING SYSTEM (OTS)
K001950 · Radionics, Inc. · Jul 2000
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
K001431 · Radionics, Inc. · May 2000
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K992461 · Surgical Navigation Technologies, Inc. · Feb 2000
VOYAGER 6.0 SOFTWARE OPTION
K000310 · Philips Medical Systems (Cleveland), Inc. · Feb 2000