510(k) K223615
- Device
- Digital ClarusScope System, Digital NeuroPEN System
- Applicant
- Clarus Medical, LLC
- 510(k) number
- K223615
- Product code
- GWG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-11-21
- Date received
- 2022-12-05
- Regulation
- 882.1480
- Classification name
- Endoscope, Neurological
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Mark F. Brown
- Address
- 13355 10th Ave. N Suite 110 Plymouth MN US 55441 55441
FDA Registration Numbers#
- 2432235
- 8010510
- 3004608878
- 2183911
- 9614434
- 3009420598
- 3005168196
- 1221826
- 2244478
- 3012447612
- 3013758550
- 3015615738
- 3025482817
- 3020703212
- 8010168
- 3008837339
- 3018094310
- 3013247477
- 9681191
- 8020888
- 3005809810
- 1721676
- 9615010
- 3009538961
- 3021744379
- 2020550
- 3024021261
- 3025341449
- 2027009
- 2029275
- 3016591327
- 2936485
- 3007303113
- 3010707607
- 3006546082
- 3012322232
- 3010177712
- 3010202439
- 1000343527
- 1418479
- 3015531529
- 9614945
- 3028006458
- 3003418325
- 8010487
- 3002807090
- 3016050940
- 3003915875
- 9610617
- 3013505638
- 2011171
- 3003713161
- 3015967359
- 9610612
- 3010034260
- 1219913
- 3015449142
- 3004542960
- 3016099036
- 2916714
- 9611102
- 2183744
- 3014342096
Source Documents#
Other 510(k) Records For Product Code GWG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253602 | Precision S 4K Sinuscope | Stryker Endoscopy | 2026-06-04 |
| K253679 | Hydro Irrigation System | Stryker Instruments | 2026-05-08 |
| K243429 | HJY VisualNext 3D Endoscopic Vision System | Hjy Smart Medical Device Co., Ltd. | 2025-05-21 |
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) | Integra LifeSciences Corporation | 2025-04-09 |
| K233391 | cCeLL - In vivo | VPIX Medical, Inc. | 2024-08-21 |
| K232618 | Aurora Surgiscope System | Rebound Therapeutics Corporation | 2023-10-27 |
| K230125 | Neuroblade System | Clearmind Biomedical | 2023-10-13 |
| K232159 | QEVO System | Carl Zeiss Meditec, AG | 2023-09-21 |
| K222735 | HJY VisualNext Endoscopic Vision System | Hjy Smart Medical Device Co., Ltd. | 2023-07-28 |
| K211202 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes | Stryker | 2021-08-06 |
| K210251 | ClearPath Disposable Introducer | Clearmind Biomedical | 2021-04-02 |
| K200925 | Clarus Peel-Away Introducer Sheath | Clarus Medical, LLC | 2021-03-18 |
| K201308 | Axonpen, Axonmonitor, Axonbox, Tablet | Clearmind Biomedical | 2020-11-27 |
| K201840 | Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) | Rebound Therapeutics | 2020-11-04 |
| K191861 | Aurora Surgiscope System | Rebound Therapeutics | 2019-12-06 |