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

    IUR FLUID MANAGEMENT SYSTEM

    K Number: K031616 · Decision Aug 13, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    55
    Applicant Total
    15
    Review Days
    82

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    Basic Information

    Device Name
    IUR FLUID MANAGEMENT SYSTEM
    K Number
    K031616
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.1700
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    W.O.M. World of Medicine AG
    Date Received
    May 23, 2003
    Decision Date
    August 13, 2003
    Product Code
    HIG
    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
    HIG Insufflator, Hysteroscopic

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    Other Clearances by W.O.M. World of Medicine AG

    K Number Device Name
    K123732 HYSTEROSCOPY PUMP HM6
    K112642 AQUILEX FLUID CONTROL SYSTEM H112
    K063367 45L CORE INSUFFLATOR, MODEL F114
    K062380 FLOSIMPLE ARTHROSCOPY PUMP A120
    K060723 40 L HIGH FLOW INSUFFLATOR F113
    K042457 URO PRO
    K030837 40 L HIGH FLOW INSUFFLATOR F108
    K033927 ARTHOSCOPY PUMP A115
    K032023 W.O.M. LASER U100PLUS
    K022721 UROPOWER
    Search all 15 clearances from W.O.M. World of Medicine AG →