Cleared Special

K050438 - STEALTHSTATION SYSTEM UPDATE

K050438 is an FDA 510(k) clearance for STEALTHSTATION SYSTEM UPDATE, 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 100-day FDA review.

K050438 · Medtronic Surgical Navigation Technologies · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
100d
Days
Class 2
Risk

K050438 is an FDA 510(k) clearance for the STEALTHSTATION SYSTEM UPDATE. 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 June 2, 2005 after a review of 100 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K050438

510(k) Number K050438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2005
Decision Date June 02, 2005
Days to Decision 100 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
49d faster than avg
Panel avg: 149d · This submission: 100d
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 K050438.
ACUMEN IMAGE GUIDED SURGICAL SYSTEM
K051724 · Ebi, L.P. · Jul 2005
STELTHSTATION WIRELESS SURGEON MOUSE
K051029 · Medtronic Surgical Navigation · Jun 2005
SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM
K031196 · Praxim · Jun 2005
MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01
K041897 · Schaerer Mayfield USA, Inc. · Jun 2005
NAVIPRO SHOULDER SOFTWARE MODULE
K050897 · Kinamed, Inc. · May 2005
IPLAN! DIGITAL TEMPLATING
K042543 · Brainlab AG · May 2005
K050438 · STEALTHSTATION SYSTEM UPDATE
Download PDF FDA Summary Medtronic Surgical Na…