BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G

    K Number: K010410 · Decision Jun 20, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    24
    Review Days
    128

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    Basic Information

    Device Name
    JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G
    K Number
    K010410
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Jms Co., Ltd.
    Date Received
    February 12, 2001
    Decision Date
    June 20, 2001
    Product Code
    FOZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by Jms Co., Ltd.

    K Number Device Name
    K002352 JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE
    K002394 JMS APHERESIS NEEDLE SET ACCORDION TYPE
    K010406 JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G
    K000845 MODIFICATION TO JMS A.V. FISTULA NEEDLE SET
    K000843 MODIFICATION TO JMS APHERESIS NEEDLE
    K991904 MODIFICATION OF JMS NEEDLES AND JMS SYRINGES
    K990470 JMS A. V. FISTULA NEEDLE SET
    K990510 JMS APHERESIS NEEDLE
    K983707 JMS DIALYZER PRIMING SET
    K974902 JMS APHERESIS NEEDLE
    Search all 24 clearances from Jms Co., Ltd. →