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

    Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)

    K Number: K240297 · Decision May 3, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    13
    Applicant Total
    5
    Review Days
    92

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    Basic Information

    Device Name
    Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)
    K Number
    K240297
    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
    Us Medical Innovations, LLC
    Date Received
    February 1, 2024
    Decision Date
    May 3, 2024
    Product Code
    OAB
    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
    OAB Low Energy Direct Current Thermal Ablation System

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    Other Clearances by Us Medical Innovations, LLC

    K Number Device Name
    K212736 Canady Flex RoboWrist
    K192124 Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories
    K113500 CANADY VIEIRA HYBRID PLASMA SCALPEL
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