# K222261: Flexible Video-Choledochoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai SeeGen Photoelectric Technology Co., Ltd.
- Decided: Apr 20, 2023 after 266 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K182799: Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads, Arthrex, Inc. (2019). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K182899: SpyGlass DS II Access and Delivery Catheter. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K243535: Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) (2025), 0 descendants of its own

## Indications for use
The Flexible Video-Choledochoscope System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The Flexible Video-Choledochoscope System comprises two components: the Flexible Video-Choledochoscope and Imaging Processor System (Including Light Source). 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. The imaging processor system (including the light source) provides illumination for Flexible Video-Choledochoscope and is also used to receive the signal from the endoscope, then convert it into an image and display it on the examination monitor.

Source page: https://510kreport.com/device/K222261
Methodology: https://510kreport.com/methodology