# K231105: Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai AnQing Medical Instrument Co., Ltd.
- Decided: Oct 17, 2023 after 181 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: 2 generations back to K843084 (1985). 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)
- K081456: Olympus CHF Type V, Olympus Medical Systems Corporation (2008) Summary page 5.

## Indications for use
AnQing Medical Flexible Choledochoscope has been designed to be used with the video processor, monitor, endotherapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the bile duct. The Flexible Choledochoscope is designed for use in adults.

Source page: https://510kreport.com/device/K231105
Methodology: https://510kreport.com/methodology