BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE

    K Number: K134006 · Decision Nov 21, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    4
    Review Days
    329

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    Basic Information

    Device Name
    DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE
    K Number
    K134006
    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
    Modern Medical Equipment Manufacturing Limited
    Date Received
    December 27, 2013
    Decision Date
    November 21, 2014
    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 Modern Medical Equipment Manufacturing Limited

    K Number Device Name
    K170703 Single Use Arthroscopic Electrode (with Pencil)
    K163442 Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)
    K152059 Disposable General Electrode