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

    Microwave Ablation Generator (KY-2000A, KY-2100A)

    K Number: K241827 · Decision Sep 26, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    67
    Applicant Total
    5
    Review Days
    94

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    Basic Information

    Device Name
    Microwave Ablation Generator (KY-2000A, KY-2100A)
    K Number
    K241827
    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
    Canyon Medical, Inc.
    Date Received
    June 24, 2024
    Decision Date
    September 26, 2024
    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.

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    Other Clearances by Canyon Medical, Inc.

    K Number Device Name
    K250209 Polyvinyl Alcohol Embolic Microspheres
    K241825 Microwave Ablation Antennas
    K233031 M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle
    K222865 M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle