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

    HITEMP. TM 2 LOOPTIP CAUTERY

    K Number: K802942 · Decision Feb 4, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    13
    Review Days
    77

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    Basic Information

    Device Name
    HITEMP. TM 2 LOOPTIP CAUTERY
    K Number
    K802942
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Medical Products Development, Inc.
    Date Received
    November 19, 1980
    Decision Date
    February 4, 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 Medical Products Development, Inc.

    K Number Device Name
    K810013 MULTIPERFECTEMP CAUTERY
    K810012 MULTIMICRO SURGICAL CAUTERY
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    K803067 SURG-FLEX 10 LIGHT
    K810015 MULTIHI-TEMP CAUTERY
    K810014 REPLACABLE BATTERY HI-TEMP CAUTERY
    K810018 SURG-FLEX 5 SURGICAL LIGHT
    K810019 SURG-FLEX 15 SURGICAL LIGHT
    K810017 MICROSURG CAUTERY
    K802330 HI-TEMP LOOPTIP SURGICAL CAUTERY
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