NLP · Drills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed
Neurology · 21 CFR 882.4305 · Class 2
Overview
| Product Code | NLP |
|---|---|
| Device Name | Drills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed |
| Regulation | 21 CFR 882.4305 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
Powered compound cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments employ a clutch mechanism to disengage the tip of the instrument after penetrating the skull to prevent plunging of the tip into the brain.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
