# K080586: Olympus XCHF Type B180Y1

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: May 6, 2008 after 64 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
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) XCHF-BP160F Choledochoscope: named in the summary without a submission number

## Most influential descendants
- K142922: SpyGlass DS Direct Visualization System (2015), 9 descendants of its own
- 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

## Indications for use
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the biliary tract and pancreatic duct in conjunction with the EVIS Duodenoscopes with an instrument channel with a minimum diameter of ø4.2mm.

Source page: https://510kreport.com/device/K080586
Methodology: https://510kreport.com/methodology