HJY VisualNext 3D Endoscopic Vision System
FDA 510(k) K243429 · Hjy Smart Medical Device Co., Ltd.
510(k) numberK243429
Submission
- Device name
- HJY VisualNext 3D Endoscopic Vision System
- Applicant
- Hjy Smart Medical Device Co., Ltd.
Taipei, TW - Received
- November 5, 2024
- Decision date
- May 21, 2025
- 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).
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| K222735 | HJY VisualNext Endoscopic Vision SystemGWG · Traditional | Hjy Smart Medical Device Co., Ltd. | 07/28/2023SE |
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More from Stryker
| 510(k) | Device | Decision |
|---|---|---|
| K222735 | HJY VisualNext Endoscopic Vision SystemGWG · Traditional | 07/28/2023SE |
Questions and answers
When was HJY VisualNext 3D Endoscopic Vision System cleared by the FDA?
HJY VisualNext 3D Endoscopic Vision System (K243429) received a 510(k) decision of Substantially Equivalent on May 21, 2025, 197 days after the submission was received.
What is the product code of K243429?
The FDA product code is GWG – Endoscope, Neurological, a Class II (moderate risk) device regulated under 21 CFR 882.1480.