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

    MILEX BARTHOLIN GLAND CATHETER

    K Number: K861385 · Decision Jun 16, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    57
    Applicant Total
    8
    Review Days
    63

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    Basic Information

    Device Name
    MILEX BARTHOLIN GLAND CATHETER
    K Number
    K861385
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Milex Products, Inc.
    Date Received
    April 14, 1986
    Decision Date
    June 16, 1986
    Product Code
    KNA
    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
    KNA Instrument, Manual, Specialized Obstetric-Gynecologic

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    Other Clearances by Milex Products, Inc.

    K Number Device Name
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    K882628 ENDO C BRUSH
    K862410 MILEX KEGEL PERINEAL EXERCISER
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