Cleared Special

K030106 - STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE

K030106 is an FDA 510(k) clearance for STEALTHSTATION SYSTEM ADVANCED CONTOUR ..., manufactured by Medtronic Surgical Navigation Technologies. The device is a Class 2 Neurology device with product code HAW cleared through the Special 510(k) pathway after a 30-day FDA review.

K030106 · Medtronic Surgical Navigation Technologies · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
30d
Days
Class 2
Risk

K030106 is an FDA 510(k) clearance for the STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Medtronic Surgical Navigation Technologies (Louisville, US). The FDA issued a Cleared decision on February 12, 2003 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K030106

510(k) Number K030106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2003
Decision Date February 12, 2003
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 149d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 426
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K030106.
IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM
K030552 · Medtronic Surgical Navigation Technologies · Mar 2003
NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000
K024201 · Image-Guided Neurologics, Inc. · Mar 2003
NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES
K023949 · Image-Guided Neurologics, Inc. · Feb 2003
NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200
K022364 · Orthosoft, Inc. · Feb 2003
STRYKER NAVIGATION SYSTEM - HIP MODULE
K022365 · Stryker Instruments · Jan 2003
CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM
K022126 · Medtronic Surgical Navigation Technologies · Jan 2003
K030106 · STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE
Download PDF FDA Summary Medtronic Surgical Na…