# K232997: EVIS Exera III Gastrointestinal Videoscope GIF-1TH190

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Jun 19, 2024 after 271 days
- Product code: FDS (Gastroscope 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
Longest line of descent: 9 generations back to K931154 (1993). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112680: Evis Exera Iii Video System, Olympus Medical Systems Corporation (2012) Summary page 7.

## Most influential descendants
- K251986: Auxiliary Water Tube Maj-855 (2025), 0 descendants of its own

## Recalls of this device
- Oct 31, 2024 · Class II · Z-0620-2025: High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor ("AER") has been removed as a compatible reprocessing method from the Instructions fo
- Sep 18, 2024 · Class II · Z-0498-2025: To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified when completing a H

## 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-1TH190 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).

Source page: https://510kreport.com/device/K232997
Methodology: https://510kreport.com/methodology