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

    BIPOLAR COAGULATING FORCEPS

    K Number: K811820 · Decision Jul 28, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    18
    Review Days
    29

    Basic Information

    Device Name
    BIPOLAR COAGULATING FORCEPS
    K Number
    K811820
    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
    June 29, 1981
    Decision Date
    July 28, 1981
    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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    K872271 VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPS
    K872209 ARTHROPLASTY MALLET
    K864770 SUCTION TUBE
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