# K243535: Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)

- Pathway: 510(k) (Special)
- Applicant: Shanghai SeeGen Photoelectric Technology Co., Ltd.
- Decided: Mar 7, 2025 after 112 days
- Product code: FBN (Choledochoscope And Accessories, Flexible/Rigid)
- 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: 1 generation back to K222261 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222261: Flexible Video-Choledochoscope System, Shanghai SeeGen Photoelectric Technology Co., Ltd. (2023) Summary page 5.

## Indications for use
The Flexible Video-Choledochoscope is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

Source page: https://510kreport.com/device/K243535
Methodology: https://510kreport.com/methodology