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

    Microwave Ablation System

    K Number: K183153 · Decision Jul 8, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    64
    Applicant Total
    7
    Review Days
    236

    Basic Information

    Device Name
    Microwave Ablation System
    K Number
    K183153
    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
    Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
    Date Received
    November 14, 2018
    Decision Date
    July 8, 2019
    Product Code
    NEY
    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
    NEY System, Ablation, Microwave And Accessories

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    Other Clearances by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

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