# K250701: Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Jun 5, 2025 after 90 days
- Product code: FDT (Duodenoscope 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: 4 generations back to K080403 (2008). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202661: Evis Exera III Duodenovideoscope Olympus TJF-Q190V, Olympus Medical Systems Corp. (2020) Summary page 6.

## Most influential descendants
- K251867: Evis Exera Iii Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) (2025), 0 descendants of its own

## Indications for use
The EVIS EXERA IIl DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V has been designed to be used with a video system center, light source, documentation equipment, 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/K250701
Methodology: https://510kreport.com/methodology