# K180731: Ultramatrix EUS Balloon

- Pathway: 510(k) (Special)
- Applicant: United States Endoscopy Group, Inc. (Us Endoscopy)
- Decided: Apr 19, 2018 after 30 days
- Product code: ODG (Endoscopic Ultrasound System, Gastroenterology-Urology)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
For endoscopic ultrasound applications using the balloon method in the upper or lower gastrointestinal tract.

Source page: https://510kreport.com/device/K180731
Methodology: https://510kreport.com/methodology