510(k) · Neurology

Stealth AXiS Cranial clinical application

by Medtronic Navigation, Inc.

Stealth AXiS Cranial clinical application is an AI-enabled medical device from Medtronic Navigation, Inc. that the U.S. FDA cleared through 510(k) K253379 on March 26, 2026. Its lead review panel is Neurology and its primary product code is HAW (Neurological Stereotaxic Instrument).

See also FDA-cleared AI neurology devices in 2026, all FDA AI clearances in 2026, top neurology AI devices.

Key facts

Submission numberK253379
Pathway510(k)
Date of final decision
Company (FDA list)Medtronic Navigation, Inc.
Lead review panelNeurology
Primary product codeHAW — Neurological Stereotaxic Instrument
Applicant (openFDA)Medtronic Navigation, Inc.
Applicant locationLafayette, CO, US
Device classClass 2
Regulation number21 CFR 882.4560
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Stealth AXiS Cranial clinical application went through this pathway (K253379).

openFDA lists it as a Class 2 device under 21 CFR 882.4560. Class II devices are moderate risk and are subject to general and special controls.

Product code HAW covers 8 devices on the FDA AI list. By decision date, this device is #8 of 8 under that code. Medtronic Navigation, Inc. has 3 AI-enabled devices on the list, and the Neurology panel accounts for 73 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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