# K052194: Spyglass Direct Visualization Probe and Ocular

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Aug 24, 2005 after 13 days
- Product code: ODF (Mini Endoscope, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K963354 (1997). 2 ancestors in all.
20 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050403: Spyglass Direct Visulation Probe, Boston Scientific Corp (2005) Summary page 1.

## Most influential descendants
- K090170: Spyscope Access and Delivery Catheter (2009), 10 descendants of its own
- K142922: SpyGlass DS Direct Visualization System (2015), 9 descendants of its own
- K122042: Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes (2012), 8 descendants of its own
- K181439: SpyGlass DS and DS II Direct Visualization System (2018), 7 descendants of its own
- K150831: Cellvizio 100 Series System with Confocal Miniprobes (2015), 7 descendants of its own

## Recalls of this device
- Feb 7, 2007 · Not classified · Z-0697-2007: SpyGlass Probe and Ocular: Ocular is out of specification and during disconnect may damage probe
- Feb 7, 2007 · Not classified · Z-0696-2007: SpyGlass Probe and Ocular: Ocular is out of specification and during disconnect may damage probe

## Indications for use
The proposed SpyGlass Direct Visualization Probe is intended to provide direct visualization for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

Source page: https://510kreport.com/device/K052194
Methodology: https://510kreport.com/methodology