GWG — Endoscope, Neurological Class II
FDA product code GWG covers "Endoscope, Neurological", a Class II medical device regulated under 21 CFR 882.1480. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K253602 | stryker endoscopy | Precision S 4K Sinuscope | June 4, 2026 |
| K253679 | stryker instruments | Hydro Irrigation System | May 8, 2026 |
| 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 |