21 CFR 882.4600 — Leukotome
Neurology (NE) · Part 882 Subpart E—Neurological Surgical Devices · § 882.4600
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GXE | Leukotome | 1 | 1 |
