Cleared Traditional

K231976 - StealthStation Cranial Software, v3.1.5 (9735585) (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231976 · Medtronic Navigation, Inc. · Neurology device
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Oct 2023
Decision
108d
Days
Class 2
Risk

K231976 is an FDA 510(k) clearance for the StealthStation Cranial Software, v3.1.5 (9735585). Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Medtronic Navigation, Inc. (Lafayette, US). The FDA issued a Cleared decision on October 19, 2023 after a review of 108 days - within the typical 510(k) review window.

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 Navigation, Inc. devices

Submission Details

510(k) Number K231976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2023
Decision Date October 19, 2023
Days to Decision 108 days
Submission Type Traditional
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
40d faster than avg
Panel avg: 148d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 422
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K231976.
Zeta Navigation System
K253663 · Zeta Surgical, Inc. · May 2026
Stealth AXiS Cranial clinical application
K253379 · Medtronic Navigation, Inc. · Mar 2026
NeuroAlign software
K231897 · Medivis, Inc. · Oct 2025
SOLOPASS 2.0 System
K251317 · Intravent Medical Partners · Sep 2025
Ball Joint Guide Array (66295)
K250893 · Bayer Medical Care, Inc. · Sep 2025
EZ-FIDUCIALS
K250505 · Phasor Health, LLC · Jul 2025