BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    CROMA Electrosurgical Generator (PRD-EMR-050)

    K Number: K242983 · Decision Feb 5, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    10
    Review Days
    132

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    Basic Information

    Device Name
    CROMA Electrosurgical Generator (PRD-EMR-050)
    K Number
    K242983
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Creo Medical, Ltd.
    Date Received
    September 26, 2024
    Decision Date
    February 5, 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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