Cleared Special

K001153 - MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM

K001153 is an FDA 510(k) clearance for MODIFICATION TO STEATHSTATION TREATMENT..., manufactured by Medtronic Surgical Navigation. The device is a Class 2 Neurology device with product code HAW cleared through the Special 510(k) pathway after a 23-day FDA review.

K001153 · Medtronic Surgical Navigation · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
23d
Days
Class 2
Risk

K001153 is an FDA 510(k) clearance for the MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Medtronic Surgical Navigation (Broomfield, US). The FDA issued a Cleared decision on May 3, 2000 after a review of 23 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.

FDA 510(k) Submission Details - K001153

510(k) Number K001153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2000
Decision Date May 03, 2000
Days to Decision 23 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
126d faster than avg
Panel avg: 149d · This submission: 23d
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 K001153.
STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM
K001284 · Medtronic Surgical Navigation Technologies · Jun 2000
SELF ADHERING NAVIGUS GUIDE
K001192 · Image-Guided Neurologics, Inc. · Jun 2000
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
K001431 · Radionics, Inc. · May 2000
CBYON SURGICAL OPERATING SYSTEM (SOS)
K000171 · Cbyon, Inc. · Mar 2000
SNN STEREOTAXIC PLANNING APPLICATION
K994421 · Surgical Navigation Specialists, Inc. · Feb 2000
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K992461 · Surgical Navigation Technologies, Inc. · Feb 2000
K001153 · MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM
Download PDF FDA Summary Medtronic Surgical Na…