# K243429: HJY VisualNext 3D Endoscopic Vision System

- Pathway: 510(k) (Traditional)
- Applicant: Hjy Smart Medical Device Co., Ltd.
- Decided: May 21, 2025 after 197 days
- Product code: GWG (Endoscope, Neurological)
- Device class: 2
- Regulation: 21 CFR 882.1480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K170667 (2017). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222735: HJY VisualNext Endoscopic Vision System, Hjy Smart Medical Device Co., Ltd. (2023) Summary page 5.

## Indications for use
HJY VisualNext 3D Endoscopic Vision System is intended for viewing internal surgical sites during general surgical procedures and for use in visualization of structures within the brain during neurological surgical procedures as well as for viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy.

Source page: https://510kreport.com/device/K243429
Methodology: https://510kreport.com/methodology