Cleared Traditional

K162309 - StealthStation S8 System Platforms and StealthStation Cranial Software

K162309 is an FDA 510(k) clearance for StealthStation S8 System Platforms and ..., 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 226-day FDA review.

K162309 · Medtronic Navigation, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K162309

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.

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 K162309.
Fiagon Navigation System
K163209 · Fiagon GmbH · Sep 2017
NaviENT
K163439 · Claronav, Inc. · 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