BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    WOM HYSTEROFLATOR OP

    K Number: K922632 · Decision Mar 25, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    55
    Applicant Total
    3
    Review Days
    751

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    Basic Information

    Device Name
    WOM HYSTEROFLATOR OP
    K Number
    K922632
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1700
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    W.O.M. GmbH
    Date Received
    March 4, 1992
    Decision Date
    March 25, 1994
    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. GmbH

    K Number Device Name
    K950035 SURGIFLATOR 20
    K921086 WOM LAPAROFLATOR ELECTRONIC