Cleared Traditional

Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System

K212194 · Stryker Corporation · Neurology

Feb 2023

Decision

582d

Days

Class 2

Risk

About This 510(k) Submission

K212194 is an FDA 510(k) clearance for the Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Stryker Corporation (Freiburg, DE). The FDA issued a Cleared decision on February 16, 2023, 582 days after receiving the submission on July 14, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K212194 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 14, 2021
Decision Date	February 16, 2023
Days to Decision	582 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF