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

    THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000

    K Number: K091939 · Decision Jul 23, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    55
    Applicant Total
    5
    Review Days
    388

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    Basic Information

    Device Name
    THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000
    K Number
    K091939
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1700
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thermedx, LLC
    Date Received
    June 30, 2009
    Decision Date
    July 23, 2010
    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 Thermedx, LLC

    K Number Device Name
    K210628 X-FLO Fluid Management System
    K172048 FluidSmart
    K133799 THERMEDX FLUID MANAGMENT SYSTEM
    K102275 THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240