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

    CERTUS 140 2.45GHZ ABLATION SYSTEM

    K Number: K122217 · Decision Dec 19, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    64
    Applicant Total
    3
    Review Days
    147

    Basic Information

    Device Name
    CERTUS 140 2.45GHZ ABLATION SYSTEM
    K Number
    K122217
    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
    NEUWAVE MEDICAL, INC
    Date Received
    July 25, 2012
    Decision Date
    December 19, 2012
    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 NEUWAVE MEDICAL, INC

    K Number Device Name
    K160936 Certus 140 2.45GHz Ablation System
    K100744 CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140