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

    swiftPro System (SWF-SPS); Swift System (SWF-SYS)

    K Number: K250718 · Decision Aug 8, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    67
    Applicant Total
    2
    Review Days
    151

    Basic Information

    Device Name
    swiftPro System (SWF-SPS); Swift System (SWF-SYS)
    K Number
    K250718
    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
    Emblation Limited
    Date Received
    March 10, 2025
    Decision Date
    August 8, 2025
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NEY), ordered by most recent decision date.

    Microwave Ablation Device

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    Other Clearances by Emblation Limited

    K Number Device Name
    K240518 swiftPro™ System