Cleared Special

K150301 - NavSuite3 Kit (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K150301 · Stryker Leibinger GmbH & Co. KG - Navigation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
152d
Days
Class 2
Risk

K150301 is an FDA 510(k) clearance for the NavSuite3 Kit. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Stryker Leibinger GmbH & Co. KG - Navigation (Freiburg, DE). The FDA issued a Cleared decision on July 8, 2015 after a review of 152 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stryker Leibinger GmbH & Co. KG - Navigation devices

Submission Details

510(k) Number K150301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2015
Decision Date July 08, 2015
Days to Decision 152 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 148d · This submission: 152d
Pathway characteristics
Modification to existing cleared device.

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
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