BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Numen™ Coil Embolization System; NumenFR™ Detachment System

    K Number: K242154 · Decision Sep 30, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    184
    Applicant Total
    4
    Review Days
    69

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    Basic Information

    Device Name
    Numen™ Coil Embolization System; NumenFR™ Detachment System
    K Number
    K242154
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5950
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MicroPort NeuroTech (Shanghai) Co., Ltd.
    Date Received
    July 23, 2024
    Decision Date
    September 30, 2024
    Product Code
    HCG
    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
    HCG Device, Neurovascular Embolization

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    Other Clearances by MicroPort NeuroTech (Shanghai) Co., Ltd.

    K Number Device Name
    K260351 Numen™ Helia Coil Embolization System; NumenFR™ Detachment System
    K232955 Numen Coil Embolization System; NumenFR Detachment System
    K203625 Numen Coil Embolization System; NumenFR Detachment System