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

    SIC 8000

    K Number: K150852 · Decision Sep 3, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    156

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    Basic Information

    Device Name
    SIC 8000
    K Number
    K150852
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cosmo Technologies, Ltd.
    Date Received
    March 31, 2015
    Decision Date
    September 3, 2015
    Product Code
    PLL
    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
    PLL Submucosal Injection Agent

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