FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
HJY VisualNext Endoscopic Vision System
K Number: K222735
·
Decision Jul 28, 2023
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
92
Applicant Total
2
Review Days
322
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Basic Information
- Device Name
- HJY VisualNext Endoscopic Vision System
- K Number
- K222735
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1480
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hjy Smart Medical Device Co., Ltd.
- Date Received
- September 9, 2022
- Decision Date
- July 28, 2023
- Product Code
- GWG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GWG | Endoscope, Neurological | FDA class 2 | Neurology |
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Other Clearances by Hjy Smart Medical Device Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K243429 | HJY VisualNext 3D Endoscopic Vision System | May 21, 2025 | Substantially Equivalent |