FDA Product Code HBL: Holder, Head, Neurosurgical (skull Clamp)
Leading manufacturers include Pro-Med Instruments GmbH and Medical Bees GmbH.
FDA 510(k) Cleared Holder, Head, Neurosurgical (skull Clamp) Devices (Product Code HBL)
About Product Code HBL - Regulatory Context
510(k) Submission Activity
50 total 510(k) submissions under product code HBL since 1982, with 50 receiving FDA clearance (average review time: 128 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under HBL have taken an average of 147 days to reach a decision - up from 127 days historically. Manufacturers should account for longer review timelines in current project planning.
HBL devices are reviewed by the Neurology panel. Browse all Neurology devices →