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

    FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM

    K Number: K013946 · Decision Feb 27, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    64
    Applicant Total
    2
    Review Days
    90

    Basic Information

    Device Name
    FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM
    K Number
    K013946
    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
    AFX, INC.
    Date Received
    November 29, 2001
    Decision Date
    February 27, 2002
    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 AFX, INC.

    K Number Device Name
    K003978 AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007