21 CFR 882.4325 — Handpiece (Brace), Drill
Neurology (NE) · Part 882 Subpart E—Neurological Surgical Devices · § 882.4325
Identification
A cranial drill handpiece (brace) is a hand holder, which is used without a power source, for drills, burrs, trephines, or other cutting tools that are used on a patient's skull.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HBD | Handpiece (Brace), Drill | 1 | 0 |
