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

    SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C

    K Number: K011988 · Decision Sep 20, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    53
    Applicant Total
    5
    Review Days
    86

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    Basic Information

    Device Name
    SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C
    K Number
    K011988
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiofocus, Inc.
    Date Received
    June 26, 2001
    Decision Date
    September 20, 2001
    Product Code
    OCL
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

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    Other Clearances by Cardiofocus, Inc.

    K Number Device Name
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    K013201 CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR
    K013901 MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM)
    K993834 SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C