# K181439: SpyGlass DS and DS II Direct Visualization System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Aug 23, 2018 after 83 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.
7 later devices descend from it; 2 cite it directly.
2 of 49 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 4.

## Most influential descendants
- K183636: SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller (2019), 5 descendants of its own
- K200483: SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller (2020), 3 descendants of its own
- 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 DS and DS II Direct Visualization System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The SpyGlass DS and DS II Direct Visualization System comprises two components: the SpyScope DS Access and Delivery Catheter or SpyScope DS II Access and Delivery Catheter, and the SpyGlass DS Digital Controller. The SpyScope DS Access and Delivery Catheter and SpyScope DS II Access and Delivery Catheter are 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 DS Digital Controller is intended to provide illumination and receive, process, and output images from the SpyScope DS Access and Delivery Catheter or SpyScope DS II Access and Delivery Catheter for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.

Source page: https://510kreport.com/device/K181439
Methodology: https://510kreport.com/methodology