# K251986: Auxiliary Water Tube Maj-855

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Sep 26, 2025 after 91 days
- Product code: OCX (Endoscopic Irrigation/Suction System)
- 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: 10 generations back to K931154 (1993). 37 ancestors in all.
No later device cites it as a predicate yet.
3 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220395: EndoGator Endoscopy Irrigation Tubing, STERIS Corporation (2022) Summary page 5.
- K232997: EVIS Exera III Gastrointestinal Videoscope GIF-1TH190, Olympus Medical Systems Corporation (2024) Summary page 5.

## Indications for use
The AUXILIARY WATER TUBE MAJ-855 is intended to be used to provide sterile water, detergent solution, disinfectant solution, water, and alcohol for irrigation through the auxiliary water channel of compatible endoscopes.

Source page: https://510kreport.com/device/K251986
Methodology: https://510kreport.com/methodology