FDA Product Code HBE: Drills, Burrs, Trephines & Accessories (simple, Powered)
Under FDA product code HBE, neurosurgical drills, burrs, and trephines are cleared for bone removal and shaping during intracranial and spinal procedures.
These powered or manual cutting instruments are used to perform craniotomies, drill burr holes, remove bone flaps, and shape bony surfaces during neurosurgical procedures. High-speed pneumatic or electric drills with irrigating systems minimize thermal injury to surrounding neural tissue.
HBE devices are Class II medical devices, regulated under 21 CFR 882.4310 and reviewed by the FDA Neurology panel.
Leading manufacturers include Surgify Medical OY, Nakanishi, Inc. and Biomet Microfixation.
FDA 510(k) Cleared Drills, Burrs, Trephines & Accessories (simple, Powered) Devices (Product Code HBE)
About Product Code HBE - Regulatory Context
510(k) Submission Activity
65 total 510(k) submissions under product code HBE since 1987, with 65 receiving FDA clearance (average review time: 136 days).
Submission volume has increased in recent years - 7 submissions in the last 24 months compared to 4 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under HBE have taken an average of 85 days to reach a decision - down from 142 days historically, suggesting improved FDA processing for this classification.
HBE devices are reviewed by the Neurology panel. Browse all Neurology devices →