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

    XNY Disposable Gastric Calibration Tube

    K Number: K250389 · Decision Apr 10, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    242
    Registration Numbers
    243
    Same Product Code
    648
    Applicant Total
    2
    Review Days
    58

    Basic Information

    Device Name
    XNY Disposable Gastric Calibration Tube
    K Number
    K250389
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Changzhou Xin Neng Yuan Medical Stapler Co., Ltd.
    Date Received
    February 11, 2025
    Decision Date
    April 10, 2025
    Product Code
    KNT
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KNT Tubes, Gastrointestinal (And Accessories)

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    Other Clearances by Changzhou Xin Neng Yuan Medical Stapler Co., Ltd.

    K Number Device Name
    K190029 Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar