BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    EsoFLIP® ES-310 Balloon Catheter

    K Number: K172128 · Decision Nov 22, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    12
    Review Days
    131

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    Basic Information

    Device Name
    EsoFLIP® ES-310 Balloon Catheter
    K Number
    K172128
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Crospon, Ltd.
    Date Received
    July 14, 2017
    Decision Date
    November 22, 2017
    Product Code
    PIE
    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
    PIE Esophageal Dilator With Balloon And Electrode Sensors

    Similar 510(k) Clearances

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    ESOFLIP ES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
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    Other Clearances by Crospon, Ltd.

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    K132337 ESOFLIP BALLOON DILATION CATHETER
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    K120997 BAROSTAT SOFTWARE OPTION
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