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

    Cardioblate Gemini-s Surgical Ablation Device

    K Number: K200514 · Decision Jun 3, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    53
    Applicant Total
    33
    Review Days
    93

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    Basic Information

    Device Name
    Cardioblate Gemini-s Surgical Ablation Device
    K Number
    K200514
    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
    Medtronic
    Date Received
    March 2, 2020
    Decision Date
    June 3, 2020
    Product Code
    OCL
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

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