BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Co-Ablation System with Sterile Co-Ablation Probe

    K Number: K243042 · Decision Jan 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    2
    Review Days
    124

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    Basic Information

    Device Name
    Co-Ablation System with Sterile Co-Ablation Probe
    K Number
    K243042
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hygea Medical Technology Co., Ltd.
    Date Received
    September 27, 2024
    Decision Date
    January 29, 2025
    Product Code
    GEH
    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
    GEH Unit, Cryosurgical, Accessories

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    Other Clearances by Hygea Medical Technology Co., Ltd.

    K Number Device Name
    K233140 Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)