# K050403: Spyglass Direct Visulation Probe

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Mar 4, 2005 after 15 days
- Product code: ODF (Mini Endoscope, Gastroenterology-Urology)
- 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: 1 generation back to K963354 (1997). 1 ancestor in all.
26 later devices descend from it; 4 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963354: 5 Star Medical Endoscope, Five Star Medical, Inc. (1997) Summary page 1.

## Cited in the summary but kept off the family tree
- K830393: Providone-Iodine Swabsticks, H & P Industries, Inc. (1983). Our OCR of the scanned summary read K830393, FDA’s number for Providone-Iodine Swabsticks (H & P Industries, Inc.), which shares no word with the summary’s name for the device, “Visicath Imaging Catheter”, apart from generic ones like “system”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K052194: Spyglass Direct Visualization Probe and Ocular (2005), 20 descendants of its own
- K091962: Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light Source, Model LS-200 (2009), 11 descendants of its own
- K132389: Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and Cystolflex F (Both Trade Marked (2014), 10 descendants of its own
- K090170: Spyscope Access and Delivery Catheter (2009), 10 descendants of its own
- K142922: SpyGlass DS Direct Visualization System (2015), 9 descendants of its own

## 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/K050403
Methodology: https://510kreport.com/methodology