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

    SUCTION IRRIGATION ELECTRODES AND ADAPTERS

    K Number: K100711 · Decision Jun 9, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    10
    Review Days
    89

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    Basic Information

    Device Name
    SUCTION IRRIGATION ELECTRODES AND ADAPTERS
    K Number
    K100711
    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
    March 12, 2010
    Decision Date
    June 9, 2010
    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
    K093622 AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015
    K091074 AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES
    K090979 DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES
    K072789 DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES