HBD · Handpiece (Brace), Drill
Neurology · 21 CFR 882.4325 · Class 1
Overview
| Product Code | HBD |
|---|---|
| Device Name | Handpiece (Brace), Drill |
| Regulation | 21 CFR 882.4325 |
| Device Class | Class 1 |
| Review Panel | Neurology |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
