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

    DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODE

    K Number: K945893 · Decision Dec 13, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    17
    Review Days
    11

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    Basic Information

    Device Name
    DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODE
    K Number
    K945893
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Boston Surgical Products, Inc.
    Date Received
    December 2, 1994
    Decision Date
    December 13, 1994
    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 Boston Surgical Products, Inc.

    K Number Device Name
    K972311 MODEL 20 BIPOLAR COAGULATOR
    K972350 MODEL 50 BIPOLAR COAGULATOR
    K944947 ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESS
    K953012 DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS
    K950375 DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATOR
    K951912 DISOPOSABLE & RESUABLE MONPOLAR CORD
    K951269 DISPOSABLE & REUSABLE MONOPOLAR HANDSWITHC PENCIL
    K950877 REUSABLE MONOPOLAR FORCEPS
    K945171 DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE
    K944634 ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
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