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

    EASY TRANS TIP

    K Number: K982565 · Decision Sep 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    25
    Applicant Total
    1
    Review Days
    61

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    EASY TRANS TIP
    K Number
    K982565
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2700
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carl Schuh
    Date Received
    July 23, 1998
    Decision Date
    September 22, 1998
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KXO), ordered by most recent decision date.

    SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    IUP - TIP TRANS, IUP - PROXI TRANS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all