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

    Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)

    K Number: K253222 · Decision Dec 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    112
    Applicant Total
    3
    Review Days
    84

    Basic Information

    Device Name
    Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)
    K Number
    K253222
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zhejiang Gongdong Medical Technology Co., Ltd.
    Date Received
    September 29, 2025
    Decision Date
    December 22, 2025
    Product Code
    MMK
    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
    MMK Container, Sharps

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    Other Clearances by Zhejiang Gongdong Medical Technology Co., Ltd.

    K Number Device Name
    K220739 Disposable Urine Collection Tube
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