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

    Duet External Drainage and Monitoring System (EDMS)

    K Number: K242034 · Decision Oct 24, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    28
    Review Days
    105

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    Basic Information

    Device Name
    Duet External Drainage and Monitoring System (EDMS)
    K Number
    K242034
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Neurosurgery
    Date Received
    July 11, 2024
    Decision Date
    October 24, 2024
    Product Code
    PCB
    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
    PCB External Cerebrospinal Fluid (Csf) Diversion

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