Cleared Special

K020338 - STEALTHSTATION WITH FLUOROMERGE SOFTWARE

K020338 is the FDA 510(k) clearance for STEALTHSTATION WITH FLUOROMERGE SOFTWARE by Medtronic Surgical Navigation Technologies. It is a Class 2 Neurology device (product code HAW) cleared through the Special 510(k) pathway after a 26-day FDA review.

K020338 · Medtronic Surgical Navigation Technologies · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
26d
Days
Class 2
Risk

K020338 is an FDA 510(k) clearance for the STEALTHSTATION WITH FLUOROMERGE SOFTWARE. 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 27, 2002 after a review of 26 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.

View all Medtronic Surgical Navigation Technologies devices

Submission Details

510(k) Number K020338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2002
Decision Date February 27, 2002
Days to Decision 26 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 148d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 218
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K020338.
GALILEO CAS/NAV TKR SYSTEM
K020298 · Plus Orthopedics · May 2002
ORTHOPILOT 2
K013569 · Aesculap, Inc. · Apr 2002
VECTORVISION TRAUMA
K012448 · Brainlab AG · Mar 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS
K012938 · Smith & Nephew, Inc. · Feb 2002
MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE
K013861 · Elekta Instrument AB · Dec 2001
HEMI-ARC SURGICAL NAVIGATOR
K013257 · Nuvasive, Inc. · Oct 2001