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

    HANDSWITCHING MONOPOLAR PENCIL

    K Number: K883396 · Decision Sep 13, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    18
    Review Days
    33

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    Basic Information

    Device Name
    HANDSWITCHING MONOPOLAR PENCIL
    K Number
    K883396
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    New England Surgical Instrument Corp.
    Date Received
    August 11, 1988
    Decision Date
    September 13, 1988
    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 New England Surgical Instrument Corp.

    K Number Device Name
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    K880863 BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-1200
    K880859 SURGICAL BURS
    K872271 VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPS
    K872209 ARTHROPLASTY MALLET
    K864770 SUCTION TUBE
    K864775 CHISEL (OSTEOTOME, GOUGE, ETC.)
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