BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇷 Türkiye

    Nerveblox

    K Number: K250818 · Decision Aug 15, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    150

    Basic Information

    Device Name
    Nerveblox
    K Number
    K250818
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1980
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smart Alfa Teknoloji San. Ve Tic. A.S.
    Date Received
    March 18, 2025
    Decision Date
    August 15, 2025
    Product Code
    QRG
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QRG Ultrasound Guided Nerve Block Assist

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