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

    TRITON LAPAROSCOPIC COAGULATOR INSUFFLATOR & LAVAG

    K Number: K852680 · Decision Dec 23, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    337
    Applicant Total
    8
    Review Days
    181

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    Basic Information

    Device Name
    TRITON LAPAROSCOPIC COAGULATOR INSUFFLATOR & LAVAG
    K Number
    K852680
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Multigon Industries, Inc.
    Date Received
    June 25, 1985
    Decision Date
    December 23, 1985
    Product Code
    HET
    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
    HET Laparoscope, Gynecologic (And Accessories)

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    Other Clearances by Multigon Industries, Inc.

    K Number Device Name
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    K912044 MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR
    K881263 MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER
    K882755 MODEL 500V VASCULAR SPECTRUM ANALYZER
    K863589 MODEL 600 VASCULAR DUPLEX IMAGER
    K860435 MODEL 500A VASCULAR SPECTRUM ANALYZER W/CW DOPPLER