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

    CABOT MEDICAL VARIABLE FLOW INSUFFLATOR

    K Number: K862310 · Decision Aug 12, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    38
    Review Days
    56

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    Basic Information

    Device Name
    CABOT MEDICAL VARIABLE FLOW INSUFFLATOR
    K Number
    K862310
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Cabot Medical Corp.
    Date Received
    June 17, 1986
    Decision Date
    August 12, 1986
    Product Code
    HES
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HES Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)

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    Other Clearances by Cabot Medical Corp.

    K Number Device Name
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    K951972 CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHS
    K951714 CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER
    K941743 CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP
    K934115 3000 ELECTRONIC INSUFFLATOR MODIFICATION
    K932293 CABOT MEDICAL BIPOLAR CUTTING FORCEPS
    K930954 THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV
    K932626 CABOT MEDICAL SURGIFLEX(R) SUCTION-IRRIGATION PROB
    K935786 CORSON AND NEZHAT SUCTION/IRRIGATION PROBES
    Search all 38 clearances from Cabot Medical Corp. →