21 CFR 882.4360 — Motor, Drill, Electric
Neurology (NE) · Part 882 Subpart E—Neurological Surgical Devices · § 882.4360
Identification
An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HBC | Motor, Drill, Electric | 2 | 26 | 3rd Party |