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

    BOVIE ULTRASONIC SURGICAL SYSTEM

    K Number: K855138 · Decision Nov 10, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    6
    Applicant Total
    12
    Review Days
    322

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    Basic Information

    Device Name
    BOVIE ULTRASONIC SURGICAL SYSTEM
    K Number
    K855138
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Clinical Technology Corp.
    Date Received
    December 23, 1985
    Decision Date
    November 10, 1986
    Product Code
    LBK
    Advisory Committee
    Unknown
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LBK Neurosurgical Ultrasonic Instruments

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    Other Clearances by Clinical Technology Corp.

    K Number Device Name
    K925080 TEK-LUBE
    K872867 BIOSIGN
    K880166 BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000
    K872705 BOVIE 400-CT ELECTROSURGICAL GENERATOR (UNIT)
    K854231 ELECTROSURGICAL CUTTING & COAGULATION DEVICE/ACCES
    K853507 STERI-GRIP
    K852986 GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN
    K844565 BOVIE X-10 ELECTROSURGICAL GENERATOR(UNIT)
    K841272 SICKLE-STAT HEMOGLOBIN S SCREEN KIT
    K823077 URINARY BLADDER TEMP. SENSOR #81-003
    Search all 12 clearances from Clinical Technology Corp. →