Cleared Traditional

K231976 - StealthStation Cranial Software, v3.1.5 (9735585)

K231976 is an FDA 510(k) clearance for StealthStation Cranial Software, manufactured by Medtronic Navigation, Inc.. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K231976

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.

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 331
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