# K251338: Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)

- Pathway: 510(k) (Traditional)
- Applicant: Scivita Medical Technology Co., Ltd.
- Decided: Jan 20, 2026 after 265 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: 10 generations back to K931154 (1993). 43 ancestors in all.
No later device cites it as a predicate yet.
2 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183636: SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller, Boston Scientific Corporation (2019) Summary page 5.

## Indications for use
This Single-use Video Cholangioscope is intended to use in conjunction with endoscopic image processor to provide images for diagnostic and therapeutic applications in the pancreatico-biliary system and to provide a working channel for other endoscopic accessories. This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity.

Source page: https://510kreport.com/device/K251338
Methodology: https://510kreport.com/methodology