Not Cleared Direct

DEN180062 - EchoTip Insight Portosystemic Pressure Gradient Measuring System (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN180062 · Cook Ireland, Ltd. · Gastroenterology & Urology device
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Nov 2019
Decision
366d
Days
Class 2
Risk

DEN180062 is an FDA 510(k) submission (not cleared) for the EchoTip Insight Portosystemic Pressure Gradient Measuring System. Classified as Endoscopic Transhepatic Venous Access Needle (product code QIJ), Class II - Special Controls.

Submitted by Cook Ireland, Ltd. (Limerick, IE). The FDA issued a Not Cleared (DENG) decision on November 20, 2019 after a review of 366 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1050 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 366 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Cook Ireland, Ltd. devices

Submission Details

510(k) Number DEN180062 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 19, 2018
Decision Date November 20, 2019
Days to Decision 366 days
Submission Type Direct
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
236d slower than avg
Panel avg: 130d · This submission: 366d
Pathway characteristics

Device Classification

Product Code QIJ Endoscopic Transhepatic Venous Access Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1050
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.