Cleared Traditional

K231976 - StealthStation Cranial Software

K231976 is the FDA 510(k) clearance for StealthStation Cranial Software by Medtronic Navigation, Inc.. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K231976 · Medtronic Navigation, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 217
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K231976.
ClearPointer Optical Navigation Wand
K233155 · ClearPoint Neuro, Inc. · Jan 2024
Zeta Cranial Navigation System (ZNS131-US)
K233903 · Zeta Surgical, Inc. · Jan 2024
ClearPoint System (Software Version 2.2)
K233243 · ClearPoint Neuro, Inc. · Nov 2023
ClearPoint Array System (Version 1.2)
K232102 · ClearPoint Neuro, Inc. · Sep 2023
Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
K223864 · Brainlab AG · Sep 2023
Zeta Cranial Navigation System
K230661 · Zeta Surgical · Sep 2023