Cleared Special

K150301 - NavSuite3 Kit

K150301 is an FDA 510(k) clearance for NavSuite3 Kit, manufactured by Stryker Leibinger GmbH & Co. KG - Navigation. The device is a Class 2 Neurology device with product code HAW cleared through the Special 510(k) pathway after a 152-day FDA review.

K150301 · Stryker Leibinger GmbH & Co. KG - Navigation · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K150301

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 149d · This submission: 152d
Pathway characteristics
Modification to existing cleared device.

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 426
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K150301.
ROSA Brain
K151359 · Medtech S.A · Dec 2015
SYMBIS Surgical System
K143420 · Imris, Inc. · Oct 2015
ClearPoint System
K142505 · Mri Interventions, Inc. · Oct 2015
Synergy Cranial
K150216 · Medtronic Navigation, Inc. · Jun 2015
MDT Navigable Brain Biopsy Cannula
K143241 · Izi Medical Products, LLC · Apr 2015
BRIGHTMATTER NAVIGATION SYSTEM
K142024 · Synaptive Medical, Inc. · Apr 2015
K150301 · NavSuite3 Kit
Download PDF FDA Summary Stryker Leibinger Gmb…