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

    hygh-tec Drainage II

    K Number: K242336 · Decision Jan 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    1
    Review Days
    163

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    Basic Information

    Device Name
    hygh-tec Drainage II
    K Number
    K242336
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Amb Medtec
    Date Received
    August 7, 2024
    Decision Date
    January 17, 2025
    Product Code
    KNT
    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
    KNT Tubes, Gastrointestinal (And Accessories)

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