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

    Wilson-Cook Achalasia Balloon

    K Number: K182895 · Decision Jan 25, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    2
    Applicant Total
    125
    Review Days
    102

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    Basic Information

    Device Name
    Wilson-Cook Achalasia Balloon
    K Number
    K182895
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wilson-Cook Medical, Inc.
    Date Received
    October 15, 2018
    Decision Date
    January 25, 2019
    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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