# K222735: HJY VisualNext Endoscopic Vision System

- Pathway: 510(k) (Traditional)
- Applicant: Hjy Smart Medical Device Co., Ltd.
- Decided: Jul 28, 2023 after 322 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: 1 generation back to K170667 (2017). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170667: QEVO System with KINEVO 900, Carl Zeiss Meditec, AG (2017) Summary page 4.

## Most influential descendants
- K243429: HJY VisualNext 3D Endoscopic Vision System (2025), 0 descendants of its own

## Indications for use
HJY VisualNext™ 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/K222735
Methodology: https://510kreport.com/methodology