# K193182: Evis Exera III Duodenovideoscope Olympus TJF-Q190V

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Jan 17, 2020 after 60 days
- Product code: FDT (Duodenoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K080403 (2008). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143153: Evis Exera II Duodenovideoscope Olympus TJF Type Q180V, Olympus Medical Systems Corp. (2016) Summary page 5.

## Most influential descendants
- K202661: Evis Exera III Duodenovideoscope Olympus TJF-Q190V (2020), 4 descendants of its own
- K250701: Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) (2025), 1 descendant of its own
- K220587: Evis Exera III Duodenovideoscope Olympus TJF-Q190V (2022), 1 descendant of its own
- K253646: Single Use Distal Cover MAJ-2315 (MAJ-2315) (2026), 0 descendants of its own
- K251867: Evis Exera Iii Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) (2025), 0 descendants of its own

## Recalls of this device
- Sep 25, 2023 · Class II · Z-0346-2024: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the poten
- Jul 27, 2023 · Class II · Z-2467-2023: Recent reports of patient infection.
- Apr 18, 2023 · Class II · Z-1613-2023: The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover could include the risk of aspiration, inhalation, o
- Jan 28, 2021 · Class II · Z-1292-2021: Olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated with the forceps elevator region of the TJF-Q190V duodenoscope, including the distal cover (model MAJ- 2

## Indications for use
This instrument has been designed 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 for endoscopy and endoscopic surgery within the duodenum.

Source page: https://510kreport.com/device/K193182
Methodology: https://510kreport.com/methodology