Cleared Special

K022414 - STEALTHSTATION SYSTEM THREE DIMENSIONAL...

K022414 is the FDA 510(k) clearance for STEALTHSTATION SYSTEM THREE DIMENSIONAL... by Medtronic Surgical Navigation Technologies. It is a Class 2 Neurology device (product code HAW) cleared through the Special 510(k) pathway after a 21-day FDA review.

K022414 · Medtronic Surgical Navigation Technologies · Neurology device
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Aug 2002
Decision
21d
Days
Class 2
Risk

K022414 is an FDA 510(k) clearance for the STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE. 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 August 14, 2002 after a review of 21 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 K022414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2002
Decision Date August 14, 2002
Days to Decision 21 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
127d faster than avg
Panel avg: 148d · This submission: 21d
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 K022414.
SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS
K021815 · Smith & Nephew, Inc. · Oct 2002
IPLAN
K020631 · Brainlab AG · Sep 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS
K022460 · Smith & Nephew, Inc. · Aug 2002
ORTHOPILOT HTO MODULE
K021327 · Aesculap, Inc. · Jul 2002
KOLIBRI IGS SYSTEMS
K014256 · Brainlab AG · Jul 2002
ENDOMAP
K014113 · Siemens Medical Solutions USA, Inc. · Jun 2002