Cleared Traditional

K022126 - CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM

K022126 is an FDA 510(k) clearance for CATHETER INTRODUCER FOR THE STEALTHSTAT..., manufactured by Medtronic Surgical Navigation Technologies. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K022126 · Medtronic Surgical Navigation Technologies · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
186d
Days
Class 2
Risk

K022126 is an FDA 510(k) clearance for the CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM. 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 January 3, 2003 after a review of 186 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Surgical Navigation Technologies devices

FDA 510(k) Submission Details - K022126

510(k) Number K022126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2002
Decision Date January 03, 2003
Days to Decision 186 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 148d · This submission: 186d
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 334
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K022126.
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
STRYKER NAVIGATION SYSTEM - HIP MODULE
K022365 · Stryker Instruments · Jan 2003
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
K021798 · Smith & Nephew, Inc. · Dec 2002
VECTORVISION CT-FREE KNEE
K021306 · Brainlab AG · Oct 2002
SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS
K021815 · Smith & Nephew, Inc. · Oct 2002