NLN · Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed
Neurology · 21 CFR 882.4310 · Class 2
Overview
| Product Code | NLN |
|---|---|
| Device Name | Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed |
| Regulation | 21 CFR 882.4310 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K041978 | REPROCESSED DIAMOND BURS | Alliance Medical Corp. | Nov 23, 2004 | SESE |
Top Applicants
- Alliance Medical Corp. — 1 clearance
