BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ESOFLIP ES

    K Number: K142000 · Decision Sep 25, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    12
    Review Days
    64

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    Basic Information

    Device Name
    ESOFLIP ES
    K Number
    K142000
    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 23, 2014
    Decision Date
    September 25, 2014
    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

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    Other Clearances by Crospon, Ltd.

    K Number Device Name
    K183072 EndoFLIP System
    K172128 EsoFLIP® ES-310 Balloon Catheter
    K170833 EndoFLIP® System with FLIP Topography module
    K160725 EndoFLIP
    K132337 ESOFLIP BALLOON DILATION CATHETER
    K130906 ENDOFLIP CATHETER
    K120997 BAROSTAT SOFTWARE OPTION
    K110531 ENDOFLIP ECD
    K110529 ENDOFLIP GASTRIC TUBE
    K102214 ENDO FLIP
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