BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Safety Blood Collection Needles with/without Needle Holder

    K Number: K220900 · Decision Aug 10, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    12
    Review Days
    135

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    Basic Information

    Device Name
    Safety Blood Collection Needles with/without Needle Holder
    K Number
    K220900
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
    Date Received
    March 28, 2022
    Decision Date
    August 10, 2022
    Product Code
    JKA
    Advisory Committee
    Clinical Chemistry
    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
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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    Other Clearances by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

    K Number Device Name
    K234024 HWJECT Auto-disable syringe
    K230061 Insulin Syringe
    K230043 Insulin Pen Needle
    K223323 Blood Collection Needle (with/without Needle Holder)
    K222124 Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle
    K222141 Safety Blood Collection Needle (Without Needle Holder)
    K220083 LDV((Low Dead Volume )Syringe
    K214075 Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)
    K211555 Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe
    K202188 Safety Blood Collection Sets for Single Use
    Search all 12 clearances from Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. →