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

    IUP - TIP TRANS, IUP - PROXI TRANS

    K Number: K961290 · Decision Oct 15, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    25
    Applicant Total
    6
    Review Days
    194

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    Basic Information

    Device Name
    IUP - TIP TRANS, IUP - PROXI TRANS
    K Number
    K961290
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2700
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Scientific Device Manufacturer, LLC
    Date Received
    April 4, 1996
    Decision Date
    October 15, 1996
    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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    LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000

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    Other Clearances by Scientific Device Manufacturer, LLC

    K Number Device Name
    K960764 SAFE-CATH
    K960431 PRESSURE STOPCOCK/MANIFOLD
    K960430 CONTROL SYRINGE
    K960917 PERCUGLIDE
    K952579 TOCO TRANSDUCER