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

    Sterile Hypodermic Syringe for Single Use

    K Number: K212207 · Decision Mar 23, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    7
    Review Days
    616

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    Basic Information

    Device Name
    Sterile Hypodermic Syringe for Single Use
    K Number
    K212207
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shandong Weigao Group Medical Polymer Co., Ltd.
    Date Received
    July 15, 2021
    Decision Date
    March 23, 2023
    Product Code
    FMF
    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
    FMF Syringe, Piston

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    Other Clearances by Shandong Weigao Group Medical Polymer Co., Ltd.

    K Number Device Name
    K212920 Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use
    K102741 ENTERAL FEEDING BAG AND SETS
    K102328 BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA
    K081241 WEIGAO EMPTY CARTRIDGE SYRINGE
    K072739 JIERUI SYRINGES AND NEEDLES
    K073127 BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G