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

    <GENX> SINGLE LUMEN SIDEPORT NEEDLE

    K Number: K991264 · Decision Sep 9, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    32
    Applicant Total
    24
    Review Days
    149

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    Basic Information

    Device Name
    <GENX> SINGLE LUMEN SIDEPORT NEEDLE
    K Number
    K991264
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6100
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    <Genx> Intl., Inc.
    Date Received
    April 13, 1999
    Decision Date
    September 9, 1999
    Product Code
    MQE
    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
    MQE Needle, Assisted Reproduction

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    Other Clearances by <Genx> Intl., Inc.

    K Number Device Name
    K112083 LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES
    K080395 SUNIVF DISHES
    K053552 GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA
    K053551 MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL
    K040530 MEDIA CULTURE SYSTEM
    K023033 ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM)
    K022590 PVP (POLYVINYLPYRROLIDONE)
    K022352 HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS)
    K022547 ACIDIFIED TYRODES SOLUTION
    K022334 HTF PLUS - HTF WITH NON-ESSENTIAL AMINO ACIDS
    Search all 24 clearances from <Genx> Intl., Inc. →