FDA Product Code HAW: Neurological Stereotaxic Instrument
Stereotaxic navigation is fundamental to neurosurgery. FDA product code HAW covers neurological stereotaxic instruments — computer-assisted systems that provide spatial guidance during intracranial procedures.
These devices register preoperative imaging to the patient's anatomy in real time, enabling surgeons to accurately localize brain targets for biopsy, electrode placement, tumor resection, and deep brain stimulation. Orthopedic stereotaxic instruments are classified separately under product code OLO.
HAW devices are Class II medical devices, regulated under 21 CFR 882.4560 and reviewed by the FDA Neurology panel.
Leading manufacturers include Brainlab AG, Medtronic Navigation, Inc. and PAJUNK GmbH Medizintechnologie.
List of Neurological Stereotaxic Instrument devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Neurological Stereotaxic Instrument devices (product code HAW). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Neurology FDA review panel. Browse all Neurology devices →