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

    THE ADVANCE CATHETER FOR HSG AND SIS

    K Number: K123258 · Decision Jan 31, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    78
    Registration Numbers
    78
    Same Product Code
    86
    Applicant Total
    8
    Review Days
    105

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    Basic Information

    Device Name
    THE ADVANCE CATHETER FOR HSG AND SIS
    K Number
    K123258
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Catheter Research, Inc.
    Date Received
    October 18, 2012
    Decision Date
    January 31, 2013
    Product Code
    LKF
    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
    LKF Cannula, Manipulator/Injector, Uterine

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    Other Clearances by Catheter Research, Inc.

    K Number Device Name
    K120154 INTRAUTERINE INSEMINATION (IUI) CATHETER
    K032835 H/S CATHETER SET
    K020292 UTERINE INJECTOR
    K973839 DISPOSABLE ESOPHAGEAL STETHOSCOPE
    K974357 UTERINE MANIPULATOR/INJECTOR
    K951345 DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING
    K946044 DISPOSABLE GAS SAMPLING LINES