BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    cCeLL - In vivo

    K Number: K233391 · Decision Aug 21, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    90
    Applicant Total
    1
    Review Days
    324

    Basic Information

    Device Name
    cCeLL - In vivo
    K Number
    K233391
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1480
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    VPIX Medical, Inc.
    Date Received
    October 2, 2023
    Decision Date
    August 21, 2024
    Product Code
    GWG
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GWG Endoscope, Neurological

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