# K024033: XTJF-160AF Duodenovideoscope

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Optical Co., Ltd.
- Decided: Dec 20, 2002 after 14 days
- Product code: FDT (Duodenoscope 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: 3 generations back to K853585 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980465: Olympus TJF-140R/JF-140R Evis Duodenovideoscopes and Accessories, Olympus Maj-311/Maj-411 Distal Covers, Olympus America, Inc. (1998) Summary page 4.
- K853585: Olympus Evs-Endoscopic Video Image & Data Sys, Olympus Corp. (1986) Summary page 4.
- K001241: Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I, The Olympus Optical Co. (2000) Summary page 4.

## Recalls of this device
- Mar 15, 2016 · Class II · Z-1845-2016: New reprocessing instructions for the Olympus TJF-160/VF duodenoscopes, consisting of revised manual cleaning and high level disinfection procedures they plan to implement as well as a new cleaning br

## Indications for use
The XTJF-160AF has been designed to be used with an Olympus EVIS video system cenler, light source, Documentation Equipment, Video Monitor, Endo-Therapy accessories (such as a Forceps, Eleclrosurgical Accessories, etc.), Electrosurgical Unit, and other Ancillary Equipment for endoscopy and endoscopic surgery within the duodenum. Do not use these instruments for any purpose other than their intended uses.

Source page: https://510kreport.com/device/K024033
Methodology: https://510kreport.com/methodology