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

    GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300

    K Number: K853291 · Decision Oct 10, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    30
    Applicant Total
    17
    Review Days
    66

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    Basic Information

    Device Name
    GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300
    K Number
    K853291
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Bio-Detek, Inc.
    Date Received
    August 5, 1985
    Decision Date
    October 10, 1985
    Product Code
    HAM
    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
    HAM Apparatus, Electrosurgical

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