Cleared Traditional

K162309 - StealthStation S8 System Platforms and ...

K162309 is the FDA 510(k) clearance for StealthStation S8 System Platforms and ... by Medtronic Navigation, Inc.. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K162309 · Medtronic Navigation, Inc. · Neurology device
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Mar 2017
Decision
226d
Days
Class 2
Risk

K162309 is an FDA 510(k) clearance for the StealthStation S8 System Platforms and StealthStation Cranial Software. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Medtronic Navigation, Inc. (Louisville, US). The FDA issued a Cleared decision on March 31, 2017 after a review of 226 days - an extended review cycle.

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 K162309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2016
Decision Date March 31, 2017
Days to Decision 226 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
78d slower than avg
Panel avg: 148d · This submission: 226d
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 K162309.
Microscope Navigation Software
K172820 · Brainlab AG · Mar 2018
Leksell Vantage Stereotactic System
K171123 · Elekta Instrument AB · Sep 2017
StealthConnect Remote Viewing, Planning and Collaboration System
K162655 · Medtronic Navigation, Inc. · Apr 2017
Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker
K162929 · Stryker Corporation · Feb 2017
Cranial Reducing Tubes
K162604 · Medtronic Navigation, Inc. · Dec 2016
CRW STEREOTACTIC SYSTEM
K160811 · Integra LifeSciences Corporation · Dec 2016