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

    DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES

    K Number: K072789 · Decision Oct 19, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    10
    Review Days
    18

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    Basic Information

    Device Name
    DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES
    K Number
    K072789
    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
    Encision, Inc.
    Date Received
    October 1, 2007
    Decision Date
    October 19, 2007
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    K122383 EM3 AEM MONITOR AEM CONNECTORS
    K122580 AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIES
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    K100711 SUCTION IRRIGATION ELECTRODES AND ADAPTERS
    K091074 AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES
    K090979 DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES