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

    MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER

    K Number: K910742 · Decision Jan 14, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    25
    Applicant Total
    55
    Review Days
    327

    Basic Information

    Device Name
    MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER
    K Number
    K910742
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2700
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    GRAPHIC CONTROLS CORP.
    Date Received
    February 21, 1991
    Decision Date
    January 14, 1992
    Product Code
    KXO
    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
    KXO Monitor, Pressure, Intrauterine

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    Other Clearances by GRAPHIC CONTROLS CORP.

    K Number Device Name
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    K974730 SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)
    K980857 MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE
    K972970 MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
    K964387 POINT OF USE II SHARPS-A-GATOR
    K964279 SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)
    K963151 MEDI-TRACE 5700 RESTING ECG ELECTRODE
    K963038 MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE
    K960968 MEDI-TRACE 200, MEDI-TRACE 200-30
    Search all 55 clearances from GRAPHIC CONTROLS CORP. →