# K200483: SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: May 21, 2020 after 84 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). 47 ancestors in all.
3 later devices descend from it; 1 cites it directly.
2 of 51 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.
- K142556: Flexible Video-Uretero-Choledochoscope System, KARL STORZ Endoscopy-America, Inc. (2014) Summary page 5.
- K912120: Urf-P2 Ureterorenofiberscope/Choledochofiberscope, Olympus Corp. (1991) Summary page 5.

## Most influential descendants
- K221784: Single-use Video Pancreaticobiliary Scope, PB Digital Controller (2023), 2 descendants of its own
- K252492: Visualized Access and Delivery Catheter; PB Digital Controller (2026), 0 descendants of its own
- K254153: Single-use Video Scope; PB Digital Controller (2026), 0 descendants of its own

## Indications for use
The SpyGlass Discover Digital System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. The SpyGlass Discover Digital System comprises two components: the SpyGlass Discover Digital Catheter and the SpyGlass Discover Digital Controller. The SpyGlass Discover Digital Catheter is intended to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The SpyGlass Discover Digital Controller is intended to provide illumination and receive, process, and output images from the SpyGlass Discover Digital Catheter for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.

Source page: https://510kreport.com/device/K200483
Methodology: https://510kreport.com/methodology