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

    ACCU-BEAM LAPAROSCOPIC SYSTEM

    K Number: K910978 · Decision Nov 7, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    9
    Review Days
    245

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    Basic Information

    Device Name
    ACCU-BEAM LAPAROSCOPIC SYSTEM
    K Number
    K910978
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Tti Medical
    Date Received
    March 7, 1991
    Decision Date
    November 7, 1991
    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 Tti Medical

    K Number Device Name
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    K951895 ACCU-BEAM 300W XENON LIGHT SOURCE
    K945648 ACCU-BEAM C02 LASER HANDPIECE
    K921208 ACCU-BEAM TUBE SET
    K895656 ACCU-BEAM WAVEGUIDE
    K890922 ACCU-BEAM YAG FIBER
    K870063 CO2 LASER BRONCHOSCOPE SET
    K870046 DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET