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

    INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX

    K Number: K100517 · Decision Apr 29, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    9
    Applicant Total
    7
    Review Days
    65

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    Basic Information

    Device Name
    INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX
    K Number
    K100517
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4400
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Instrumed International, Inc.
    Date Received
    February 23, 2010
    Decision Date
    April 29, 2010
    Product Code
    HDA
    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
    HDA Forceps, Obstetrical

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