GWG — Endoscope, Neurological Class II
Classification Details
- Product Code
- GWG
- Device Class
- Class II
- Regulation Number
- 882.1480
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243429 | hjy smart medical device co | HJY VisualNext 3D Endoscopic Vision System | May 21, 2025 |
| K250752 | integra lifesciences corporation | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) | April 9, 2025 |
| K233391 | vpix medical | cCeLL - In vivo | August 21, 2024 |
| K223615 | clarus medical | Digital ClarusScope System, Digital NeuroPEN System | November 21, 2023 |
| K232618 | rebound therapeutics corporation | Aurora Surgiscope System | October 27, 2023 |
| K230125 | clearmind biomedical | Neuroblade System | October 13, 2023 |
| K232159 | carl zeiss meditec | QEVO System | September 21, 2023 |
| K222735 | hjy smart medical device co | HJY VisualNext Endoscopic Vision System | July 28, 2023 |
| K211202 | stryker | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Preci | August 6, 2021 |
| K210251 | clearmind biomedical | ClearPath Disposable Introducer | April 2, 2021 |
| K200925 | clarus medical | Clarus Peel-Away Introducer Sheath | March 18, 2021 |
| K201308 | clearmind biomedical | Axonpen, Axonmonitor, Axonbox, Tablet | November 27, 2020 |
| K201840 | rebound therapeutics | Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control B | November 4, 2020 |
| K191861 | rebound therapeutics | Aurora Surgiscope System | December 6, 2019 |
| K190719 | penumbra | Artemis Eye System | August 30, 2019 |
| K182211 | rebound therapeutics corporation | Aurora Surgiscope System | January 18, 2019 |
| K181731 | mri interventions | MR Compatible Aspiration Kit | November 20, 2018 |
| K181116 | carl zeiss meditec | CONVIVO | October 25, 2018 |
| K180270 | mauna kea technologies | Cellvizio 100 Series Systems with Confocal Miniprobes | May 22, 2018 |
| K180146 | karl storz endoscopy america | KARL STORZ ICG Imaging System | April 17, 2018 |