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

    RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR

    K Number: K050232 · Decision Mar 11, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    2
    Applicant Total
    432
    Review Days
    38

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    Basic Information

    Device Name
    RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR
    K Number
    K050232
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Corp
    Date Received
    February 1, 2005
    Decision Date
    March 11, 2005
    Product Code
    PID
    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
    PID Esophageal Dilator Balloon With Or Without Electrode Sensors

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