Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5840](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5840) → GYZ — Stimulator, Intracerebral/Subcortical, Implanted

# GYZ · Stimulator, Intracerebral/Subcortical, Implanted

_Neurology · 21 CFR 882.5840 · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GYZ

## Overview

- **Product Code:** GYZ
- **Device Name:** Stimulator, Intracerebral/Subcortical, Implanted
- **Regulation:** [21 CFR 882.5840](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5840)
- **Device Class:** 3
- **Review Panel:** [Neurology](/submissions/NE)
- **Implant:** yes

## Identification

An implanted intracerebral/subcortical stimulator for pain relief is a device that applies electrical current to subsurface areas of a patient's brain to treat severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed within a patient's brain and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

## Classification Rationale

Class III (premarket approval).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GYZ](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GYZ)

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