# K123317: Evis Exera Iii Gastrointestinal Videoscope Olympus GIXP190N

- Pathway: 510(k) (Special)
- Applicant: Olympus Medical Systems Corporation
- Decided: Dec 11, 2012 after 47 days
- Product code: FDS (Gastroscope 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: 8 generations back to K931154 (1993). 28 ancestors in all.
No later device cites it as a predicate yet.
3 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100584: Evis Exeraii 180 System, Olympus Medical Systems Corporation (2010) Summary page 2.

## Indications for use
This instrument is intended 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. The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-XP190N is indicated for use transorally or transnasally within the upper digestive tract (including the esophagus, stomach, and duodenum).

Source page: https://510kreport.com/device/K123317
Methodology: https://510kreport.com/methodology