# K113120: CHF-Y0005

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Sep 25, 2012 after 340 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). 32 ancestors in all.
No later device cites it as a predicate yet.
3 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082576: XCHF-T160 Videoscope, Olympus Medical Systems Corporation (2008) Summary page 3.
- K032177: Gastrointestinal Videoscope Xgif-Q14OM, Xgif-2T140M Colonovideoscope XCF-Q14ML/I, XPCF-160AML/I, Olympus Opto-Electronics Co., Ltd. (2003) Summary page 2.
- K080586: Olympus XCHF Type B180Y1, Olympus Medical Systems Corporation (2008) Summary page 2.
- K100584: Evis Exeraii 180 System, Olympus Medical Systems Corporation (2010) Summary page 2.

## Indications for use
This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment. This instrument is intended to be used without a DUODENOSCOPE. The CHOLEDOCHO VIDEOSCOPE CHF-Y0005 is indicated for endoscopy and endoscopic surgery within the biliary tract and the duodenum.

Source page: https://510kreport.com/device/K113120
Methodology: https://510kreport.com/methodology