# K080403: XTJF Type Q160VF1

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: May 20, 2008 after 96 days
- Product code: FDT (Duodenoscope And Accessories, Flexible/Rigid)
- 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
No predicates in its family tree.
15 later devices descend from it; 1 cites it directly.
0 of 16 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) Olympus XTJF Type 160AF Duodenovideoscope: named in the summary without a submission number

## Most influential descendants
- K143153: Evis Exera II Duodenovideoscope Olympus TJF Type Q180V (2016), 14 descendants of its own
- K193182: Evis Exera III Duodenovideoscope Olympus TJF-Q190V (2020), 5 descendants of its own
- K202661: Evis Exera III Duodenovideoscope Olympus TJF-Q190V (2020), 4 descendants of its own
- K193202: EXALT Model D Single-Use Duodenoscope, EXALT Controller (2019), 4 descendants of its own
- K213606: EvoEndo Single-Use Endoscopy System (2022), 3 descendants of its own

## Recalls of this device
- Jan 8, 2016 · Class II · Z-0757-2016: Olympus America Inc is conducting a voluntary removal/corrective action of all TJF-Q180V duodenoscopes in order to replace the forceps elevator mechanism Olympus is replacing the forceps elevator mech
- Mar 26, 2015 · Class II · Z-2807-2015: New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope ("TJF-Q180V"), consisting of revised manual cleaning and high level disinfection procedures.

## 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 duodenum.

Source page: https://510kreport.com/device/K080403
Methodology: https://510kreport.com/methodology