Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1480](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1480) → GWG — Endoscope, Neurological

# GWG · Endoscope, Neurological

_Neurology · 21 CFR 882.1480 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/GWG

## Overview

- **Product Code:** GWG
- **Device Name:** Endoscope, Neurological
- **Regulation:** [21 CFR 882.1480](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1480)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)

## Identification

A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (20 of 93)

Showing 20 most recent of 93 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K253602](/device/K253602.md) | Precision S 4K Sinuscope | Stryker Endoscopy | Jun 4, 2026 | SESE |
| [K253679](/device/K253679.md) | Hydro Irrigation System | Stryker Instruments | May 8, 2026 | SESE |
| [K243429](/device/K243429.md) | HJY VisualNext 3D Endoscopic Vision System | Hjy Smart Medical Device Co., Ltd. | May 21, 2025 | SESE |
| [K250752](/device/K250752.md) | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) | Integra LifeSciences Corporation | Apr 9, 2025 | SESE |
| [K233391](/device/K233391.md) | cCeLL - In vivo | VPIX Medical, Inc. | Aug 21, 2024 | SESE |
| [K223615](/device/K223615.md) | Digital ClarusScope System, Digital NeuroPEN System | Clarus Medical, LLC | Nov 21, 2023 | SESE |
| [K232618](/device/K232618.md) | Aurora Surgiscope System | Rebound Therapeutics Corporation | Oct 27, 2023 | SESE |
| [K230125](/device/K230125.md) | Neuroblade System | Clearmind Biomedical | Oct 13, 2023 | SESE |
| [K232159](/device/K232159.md) | QEVO System | Carl Zeiss Meditec, AG | Sep 21, 2023 | SESE |
| [K222735](/device/K222735.md) | HJY VisualNext Endoscopic Vision System | Hjy Smart Medical Device Co., Ltd. | Jul 28, 2023 | SESE |
| [K211202](/device/K211202.md) | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes | Stryker | Aug 6, 2021 | SESE |
| [K210251](/device/K210251.md) | ClearPath Disposable Introducer | Clearmind Biomedical | Apr 2, 2021 | SESE |
| [K200925](/device/K200925.md) | Clarus Peel-Away Introducer Sheath | Clarus Medical, LLC | Mar 18, 2021 | SESE |
| [K201308](/device/K201308.md) | Axonpen, Axonmonitor, Axonbox, Tablet | Clearmind Biomedical | Nov 27, 2020 | SESE |
| [K201840](/device/K201840.md) | Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) | Rebound Therapeutics | Nov 4, 2020 | SESE |
| [K191861](/device/K191861.md) | Aurora Surgiscope System | Rebound Therapeutics | Dec 6, 2019 | SESE |
| [K190719](/device/K190719.md) | Artemis Eye System | Penumbra, Inc. | Aug 30, 2019 | SESE |
| [K182211](/device/K182211.md) | Aurora Surgiscope System | Rebound Therapeutics Corporation | Jan 18, 2019 | SESE |
| [K181731](/device/K181731.md) | MR Compatible Aspiration Kit | Mri Interventions, Inc. | Nov 20, 2018 | SESE |
| [K181116](/device/K181116.md) | CONVIVO | Carl Zeiss Meditec, AG | Oct 25, 2018 | SESE |

## Top Applicants

- Neuro Navigational Corp. — 15 clearances
- KARL STORZ Endoscopy-America, Inc. — 8 clearances
- Clarus Medical Systems, Inc. — 7 clearances
- Aesculap, Inc. — 6 clearances
- Medtronic PS Medical — 4 clearances

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**Source:** [https://fda.innolitics.com/productcode/GWG](https://fda.innolitics.com/productcode/GWG)

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