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, ClearPoint Neuro, Inc. and Medtronic Navigation, Inc..