# K250551: 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Sophway Technology Co., Ltd.
- Decided: Oct 2, 2025 after 219 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K931154 (1993). 34 ancestors in all.
No later device cites it as a predicate yet.
3 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151011: Visera 4K Uhd System, Olympus Medical Systems Corp. (2015) Summary page 5.

## Indications for use
It is used to connect with an optical endoscope during the endoscopic diagnosis, treatment, and observation. And to capture, process and transmit images in the human body cavity under the field of view observed by the endoscope to the monitor.

Source page: https://510kreport.com/device/K250551
Methodology: https://510kreport.com/methodology