NLO · Drills, Burrs, Trephines And Accessories (Manual), Reprocessed
Neurology · 21 CFR 882.4300 · Class 2
Overview
| Product Code | NLO |
|---|---|
| Device Name | Drills, Burrs, Trephines And Accessories (Manual), Reprocessed |
| Regulation | 21 CFR 882.4300 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
