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

    Sterile Hypodermic Syringes for Single Use

    K Number: K213811 · Decision May 12, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    9
    Review Days
    156

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    Basic Information

    Device Name
    Sterile Hypodermic Syringes for Single Use
    K Number
    K213811
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Berpu Medical Technology Co., Ltd.
    Date Received
    December 7, 2021
    Decision Date
    May 12, 2022
    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 Berpu Medical Technology Co., Ltd.

    K Number Device Name
    K232165 Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles
    K221045 Insulin Syringes without needle
    K220061 Safety Insulin Syringes
    K213158 Syringe with permanently attached needle
    K212514 Safety Pen Needle for Single Use, Insulin Pen Needles
    K181447 Safety insulin needle for single use
    K180417 Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use
    K162180 Disposable Insulin Syringe