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

    BIPOLAR ELECTROSURGICAL PENCIL

    K Number: K943031 · Decision Sep 23, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    11
    Applicant Total
    17
    Review Days
    88

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    Basic Information

    Device Name
    BIPOLAR ELECTROSURGICAL PENCIL
    K Number
    K943031
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4115
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Boston Surgical Products, Inc.
    Date Received
    June 27, 1994
    Decision Date
    September 23, 1994
    Product Code
    HQO
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HQO Unit, Cautery, Thermal, Ac-Powered

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    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
    K945893 DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODE
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