# K143153: Evis Exera II Duodenovideoscope Olympus TJF Type Q180V

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Jan 15, 2016 after 438 days
- Product code: FDT (Duodenoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K080403 (2008). 1 ancestor in all.
14 later devices descend from it; 4 cite 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)
- K080403: XTJF Type Q160VF1, Olympus Medical Systems Corporation (2008) Summary page 5.

## Most influential descendants
- 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
- K201098: Ambu Duodeno System (2020), 2 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
- Nov 2, 2021 · Class II · Z-0379-2022: Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infe
- Dec 17, 2018 · Class II · Z-1010-2019: The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing oper

## 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/K143153
Methodology: https://510kreport.com/methodology