# DEN180062: EchoTip Insight Portosystemic Pressure Gradient Measuring System

- Pathway: De Novo (Direct)
- Applicant: Cook Ireland, Ltd.
- Decided: Nov 20, 2019 after 366 days
- Product code: QIJ (Endoscopic Transhepatic Venous Access Needle)
- Device class: 2
- Regulation: 21 CFR 876.1050
- 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. De Novo decisions do not claim a predicate device.

## Indications for use
The EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System is indicated to directly measure pressures in the hepatic and portal venous vasculatures and is used in conjunction with an ultrasound endoscope.

Source page: https://510kreport.com/device/DEN180062
Methodology: https://510kreport.com/methodology