BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    GERDX-System

    K Number: K233240 · Decision Jun 21, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    19
    Applicant Total
    1
    Review Days
    267

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    Basic Information

    Device Name
    GERDX-System
    K Number
    K233240
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    G-Surg GmbH
    Date Received
    September 28, 2023
    Decision Date
    June 21, 2024
    Product Code
    ODE
    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
    ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)

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