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..
FDA 510(k) Cleared Neurological Stereotaxic Instrument Devices (Product Code HAW)
About Product Code HAW - Regulatory Context
510(k) Submission Activity
423 total 510(k) submissions under product code HAW since 1979, with 423 receiving FDA clearance (average review time: 141 days).
Submission volume has declined in recent years - 13 submissions in the last 24 months compared to 23 in the prior period.
FDA Review Time
Recent submissions under HAW have taken an average of 208 days to reach a decision - up from 139 days historically. Manufacturers should account for longer review timelines in current project planning.
HAW devices are reviewed by the Neurology panel. Browse all Neurology devices →