BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇳 India

    Ez Catch Auto; Ez Catch YR; Ez Catch TR

    K Number: K240205 · Decision Apr 15, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    2
    Review Days
    81

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    Basic Information

    Device Name
    Ez Catch Auto; Ez Catch YR; Ez Catch TR
    K Number
    K240205
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Veol Medical Technologies Pvt , Ltd.
    Date Received
    January 25, 2024
    Decision Date
    April 15, 2024
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Veol Medical Technologies Pvt , Ltd.

    K Number Device Name
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