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

    AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES

    K Number: K131949 · Decision Aug 26, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    10
    Review Days
    60

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    Basic Information

    Device Name
    AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES
    K Number
    K131949
    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
    June 27, 2013
    Decision Date
    August 26, 2013
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Encision, Inc.

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    K093622 AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015
    K100711 SUCTION IRRIGATION ELECTRODES AND ADAPTERS
    K091074 AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES
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