Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4600](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4600) → GXE — Leukotome

# GXE · Leukotome

_Neurology · 21 CFR 882.4600 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXE

## Overview

- **Product Code:** GXE
- **Device Name:** Leukotome
- **Regulation:** [21 CFR 882.4600](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4600)
- **Device Class:** 1
- **Review Panel:** [Neurology](/submissions/NE)

## 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](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXE/K915741.md) | DISPOSABLE MONOPLAR MEDDLE ELECTRODES | Dantec Medical, Inc. | Dec 8, 1992 | SESE |

## Top Applicants

- Dantec Medical, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXE](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GXE)

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