DeviceClearance

Product code QIJ— Gastroenterology, Urology

EchoTip Insight Portosystemic Pressure Gradient Measuring System

Classification name
Endoscopic Transhepatic Venous Access Needle
Device class
Class 2
Regulation
21 CFR 876.1050
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

FDA classification definition

“An endoscopic transhepatic venous access needle is inserted through the liver into the patient’s portal/hepatic venous system under endoscopic ultrasound guidance. It is connected to a separate device intended to measure a physiological parameter.”

— U.S. Food and Drug Administration, device classification record for product code QIJ under 21 CFR 876.1050, via openFDA

Market context for product code QIJ

FDA has cleared 1 device under product code QIJ, all in 2019, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QIJ

Recent clearances under product code QIJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.