BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Stone Retrieval Balloon

    K Number: K200173 · Decision May 1, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    25
    Applicant Total
    17
    Review Days
    99

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    Basic Information

    Device Name
    Stone Retrieval Balloon
    K Number
    K200173
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hangzhou AGS MedTech Co., Ltd.
    Date Received
    January 23, 2020
    Decision Date
    May 1, 2020
    Product Code
    GCA
    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
    GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

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    Other Clearances by Hangzhou AGS MedTech Co., Ltd.

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