Cleared Traditional

K003201 - STEALTHSTATION TREATMENT GUIDANCE PLATFORM

K003201 is an FDA 510(k) clearance for STEALTHSTATION TREATMENT GUIDANCE PLATFORM, 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 61-day FDA review.

K003201 · Medtronic Surgical Navigation Technologies · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
61d
Days
Class 2
Risk

K003201 is an FDA 510(k) clearance for the STEALTHSTATION TREATMENT GUIDANCE PLATFORM. 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 December 12, 2000 after a review of 61 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Surgical Navigation Technologies devices

FDA 510(k) Submission Details - K003201

510(k) Number K003201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2000
Decision Date December 12, 2000
Days to Decision 61 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
87d faster than avg
Panel avg: 148d · This submission: 61d
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 K003201.
Z-TOUCH
K003268 · Brainlab AG · Feb 2001
STRYKER REMOTE SURGICAL PLANNING SYSTEM
K004027 · Stryker Instruments · Jan 2001
STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES
K003111 · Stryker Instruments · Jan 2001
STRYKER NAVIGATION SYSTEM - ENT MODULE
K002732 · Stryker Corp. · Oct 2000
OPTICAL TRACKING SYSTEM (OTS)
K001950 · Radionics, Inc. · Jul 2000
SELF ADHERING NAVIGUS GUIDE
K001192 · Image-Guided Neurologics, Inc. · Jun 2000