Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart B — Diagnostic Devices](/submissions/EN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 874.1820](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/874.1820) → QWP — Optical Neurosurgical Nerve Locator

# QWP · Optical Neurosurgical Nerve Locator

_Ear, Nose, Throat · 21 CFR 874.1820 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/QWP

## Overview

- **Product Code:** QWP
- **Device Name:** Optical Neurosurgical Nerve Locator
- **Regulation:** [21 CFR 874.1820](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/874.1820)
- **Device Class:** 2
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)

## Identification

A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.

## Classification Rationale

Class II.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K222106](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/QWP/K222106.md) | Waypoint GPS | Waypoint Orthopedics, Inc. | May 12, 2023 | SESE |

## Top Applicants

- Waypoint Orthopedics, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/QWP](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/QWP)

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