Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5880](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5880) → LHG — Electrode, Spinal Epidural

# LHG · Electrode, Spinal Epidural

_Neurology · 21 CFR 882.5880 · Class 2_

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

## Overview

- **Product Code:** LHG
- **Device Name:** Electrode, Spinal Epidural
- **Regulation:** [21 CFR 882.5880](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5880)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **Implant:** yes

## Identification

An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K110609](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LHG/K110609.md) | EPIDUCER LEAD DELIVERY SYSTEM | St Jude Medical | Jun 24, 2011 | SESE |

## Top Applicants

- St Jude Medical — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
