Class Class II
HJY VisualNext 3D Endoscopic Vision System (K243429)
Description
HJY VisualNext 3D Endoscopic Vision System by Hjy Smart Medical Device Co., Ltd., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243429
Clearance Date2025-05-21
Clearance TypeTraditional
Product CodeGWG
Regulation Number882.1480
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243429
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. HJY VisualNext 3D Endoscopic Vision System (K243429) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222735 | HJY VisualNext Endoscopic Vision System | Hjy Smart Medical Device Co., Ltd. | 2023 |
| K113203 | SONY LMD-2451MT LCD MONITOR | Sony Electronics, Inc. | 2012 |
Trace the full predicate network for K243429
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.