# K231497: Choledochoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen HugeMed Medical Technical Development Co., Ltd.
- Decided: Mar 6, 2024 after 287 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: 11 generations back to K931154 (1993). 27 ancestors in all.
No later device cites it as a predicate yet.
1 of 28 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210579: WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System, OTU Medical, Inc. (2021) Summary page 5.

## Indications for use
Choledochoscope System is intended to be used by physicians through percutaneous insertion to access, visualize, and perform procedures in the pancreaticobiliary system including the hepatic ducts and the common bile duct. The image processor provides illumination for the choledochoscope, and is also used to receive the signal from the endoscope, convert it into an image and display it on the examination monitor. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site

Source page: https://510kreport.com/device/K231497
Methodology: https://510kreport.com/methodology