BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇮🇪 Ireland

    EchoTip Insight Portosystemic Pressure Gradient Measuring System

    K Number: DEN180062 · Decision Nov 20, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    0
    Applicant Total
    10
    Review Days
    366

    Basic Information

    Device Name
    EchoTip Insight Portosystemic Pressure Gradient Measuring System
    K Number
    DEN180062
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    876.1050
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    Cook Ireland Ltd.
    Date Received
    November 19, 2018
    Decision Date
    November 20, 2019
    Product Code
    QIJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QIJ Endoscopic Transhepatic Venous Access Needle

    Other Clearances by Cook Ireland Ltd.

    K Number Device Name
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    K230909 EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)
    K210476 EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle
    K172057 Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set
    K163468 Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered
    K163018 Zilver 635 Biliary Stent
    K162717 Evolution Esophageal Stent System – Partially Covered
    K160229 Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle