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

    #820/821 BIPOLAR FORCEPS

    K Number: K884175 · Decision Oct 24, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    30
    Applicant Total
    11
    Review Days
    24

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    Basic Information

    Device Name
    #820/821 BIPOLAR FORCEPS
    K Number
    K884175
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Olsen Electrosurgical, Inc.
    Date Received
    September 30, 1988
    Decision Date
    October 24, 1988
    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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    Other Clearances by Olsen Electrosurgical, Inc.

    K Number Device Name
    K922154 INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION
    K912611 OLSEN LAPAROSCOPIC INSTR, DISPOSABLE, SINGLE USE
    K913108 TEFLON COATED ELECTRODES/ELECTRODES HANDLES
    K912612 SMOKE/ODOR EVACUATOR #757
    K885200 600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE
    K885199 #500 SERIES FORCEPS W/CUT/COAGULATE SWITCHES
    K884171 #875 DISPOSABLE BIOPOLAR CABLE
    K884173 #920 DISPOSABLE TUR CABLE
    K884174 MODIFIED OLSEN 755/756 SWITCHPENS
    K884172 MODIFIED OLSEN #770 DISPOSABLE HOLSTER
    Search all 11 clearances from Olsen Electrosurgical, Inc. →