# K241444: Biliary Pancreaticobiliary Scope System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen HugeMed Medical Technical Development Co., Ltd.
- Decided: Jan 21, 2025 after 244 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: 8 generations back to K931154 (1993). 41 ancestors in all.
No later device cites it as a predicate yet.
2 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142922: SpyGlass DS Direct Visualization System, Boston Scientific Corporation (2015) Summary page 5.

## Indications for use
The Biliary Pancreaticobiliary Scope System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The Biliary Pancreaticobiliary Scope System comprises two components: the Single-use Biliary Pancreaticobiliary Scope and the Image Processor. The Single-use Biliary Pancreaticobiliary Scope is intended to provide direct visualization, illumination and to guide accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The Image Processor is intended to receive, process, and output images from the Single-use Biliary Pancreaticobiliary Scope for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

Source page: https://510kreport.com/device/K241444
Methodology: https://510kreport.com/methodology