510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN180062Unknown

EchoTip Insight Portosystemic Pressure Gradient Measuring System

Cook Ireland Ltd., Limerick, IE / Direct, Unknown
FDA source (opens on fda.gov)

DEN180062 is the FDA 510(k) clearance record for EchoTip Insight Portosystemic Pressure Gradient Measuring System, a class II device, cleared for Cook Ireland, Ltd. on under FDA product code QIJ (Endoscopic Transhepatic Venous Access Needle). FDA's definition for product code QIJ reads: "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...". FDA records list 34 510(k) clearances for Cook Ireland, Ltd., from to . As of , FDA records show no recalls naming DEN180062.

Clearance record

Decision date
Received
(366 days to decision)
Product code
QIJ Endoscopic Transhepatic Venous Access Needle
Regulation
21 CFR 876.1050
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Cook Ireland, Ltd. O' Halloran Rd., National Technology Park, Limerick, IE
Third party review
No

Clearances, product code QIJ

Trailing 12 months

FDA records hold no clearances under product code QIJ in the trailing twelve months.

FDA records show no clearances under product code QIJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QIJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260