GXE · Leukotome
Neurology · 21 CFR 882.4600 · Class 1
Overview
| Product Code | GXE |
|---|---|
| Device Name | Leukotome |
| Regulation | 21 CFR 882.4600 |
| Device Class | Class 1 |
| Review Panel | Neurology |
Identification
A leukotome is a device used to cut sections out of the brain.
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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K915741 | DISPOSABLE MONOPLAR MEDDLE ELECTRODES | Dantec Medical, Inc. | Dec 8, 1992 | SESE |
Top Applicants
- Dantec Medical, Inc. — 1 clearance
