HJY VisualNext Endoscopic Vision System
FDA 510(k) K222735 · Hjy Smart Medical Device Co., Ltd.
510(k) numberK222735
Submission
- Device name
- HJY VisualNext Endoscopic Vision System
- Applicant
- Hjy Smart Medical Device Co., Ltd.
Taipei City, TW - Received
- September 9, 2022
- Decision date
- July 28, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GWG – Endoscope, Neurological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1480
- Specialty
- Neurology
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).
Other 510(k)s with product code GWG
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|---|---|---|---|
| K253602 | Precision S 4K SinuscopeGWG · Traditional | Stryker Endoscopy | 06/04/2026SE |
| K253679 | Hydro Irrigation SystemGWG · Traditional | Stryker Instruments | 05/08/2026SE |
| K243429 | HJY VisualNext 3D Endoscopic Vision SystemGWG · Traditional | Hjy Smart Medical Device Co., Ltd. | 05/21/2025SE |
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)GWG · Special | Integra LifeSciences Corporation | 04/09/2025SE |
| K233391 | cCeLL - In vivoGWG · Traditional | VPIX Medical, Inc. | 08/21/2024SE |
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| K232618 | Aurora Surgiscope SystemGWG · Traditional | Rebound Therapeutics Corporation | 10/27/2023SE |
| K230125 | Neuroblade SystemGWG · Traditional | Clearmind Biomedical | 10/13/2023SE |
| K232159 | QEVO SystemGWG · Special | Carl Zeiss Meditec, AG | 09/21/2023SE |
| K211202 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…GWG · Traditional | Stryker | 08/06/2021SE |
More from Stryker
| 510(k) | Device | Decision |
|---|---|---|
| K243429 | HJY VisualNext 3D Endoscopic Vision SystemGWG · Traditional | 05/21/2025SE |
Questions and answers
When was HJY VisualNext Endoscopic Vision System cleared by the FDA?
HJY VisualNext Endoscopic Vision System (K222735) received a 510(k) decision of Substantially Equivalent on July 28, 2023, 322 days after the submission was received.
What is the product code of K222735?
The FDA product code is GWG – Endoscope, Neurological, a Class II (moderate risk) device regulated under 21 CFR 882.1480.