# K142922: SpyGlass DS Direct Visualization System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Jan 16, 2015 after 100 days
- Product code: FBN (Choledochoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K931154 (1993). 40 ancestors in all.
9 later devices descend from it; 4 cite it directly.
2 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060269: Acmi Dur-Digital Ureteroscope and Choledochoscope System, Acmi Corporation (2006) Summary page 4.
- K090170: Spyscope Access and Delivery Catheter, Boston Scientific Corp (2009) Summary page 4.
- K052194: Spyglass Direct Visualization Probe and Ocular, Boston Scientific Corp (2005) Summary page 5.
- K080586: Olympus XCHF Type B180Y1, Olympus Medical Systems Corporation (2008) Summary page 5.
- K082813: Stryker Led Lightsource, Stryker Corp. (2008) Summary page 5.

## Most influential descendants
- K181439: SpyGlass DS and DS II Direct Visualization System (2018), 7 descendants of its own
- 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

## Recalls of this device
- Dec 20, 2017 · Class II · Z-1133-2018: Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding.

## Indications for use
The SpyGlass DS 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 Direct Visualization System comprises two components: the SpyScope DS Access and Delivery Catheter and the SpyGlass DS Digital Controller. The SpyScope DS Access and Delivery 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 DS Digital Controller is intended to provide illumination and receive, process, and output images from the SpyScope DS Access and Delivery Catheter for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

Source page: https://510kreport.com/device/K142922
Methodology: https://510kreport.com/methodology