BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    HybridAPC probe

    K Number: K243120 · Decision Jun 20, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    839
    Registration Numbers
    839
    Same Product Code
    2251
    Applicant Total
    10
    Review Days
    263

    Basic Information

    Device Name
    HybridAPC probe
    K Number
    K243120
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Erbe Elektromedizin GmbH
    Date Received
    September 30, 2024
    Decision Date
    June 20, 2025
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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