FDA Product Code HBC: Motor, Drill, Electric
Leading manufacturers include Saeshin Precision Co., Ltd. and The Anspach Effort, Inc..
FDA 510(k) Cleared Motor, Drill, Electric Devices (Product Code HBC)
About Product Code HBC - Regulatory Context
510(k) Submission Activity
26 total 510(k) submissions under product code HBC since 1981, with 26 receiving FDA clearance (average review time: 146 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under HBC have taken an average of 361 days to reach a decision - up from 128 days historically. Manufacturers should account for longer review timelines in current project planning.
HBC devices are reviewed by the Neurology panel. Browse all Neurology devices →