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

    VedDilator ^TM (3-Stage Balloon Dilation Catheter)

    K Number: K232245 · Decision Feb 15, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    7
    Review Days
    202

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    Basic Information

    Device Name
    VedDilator ^TM (3-Stage Balloon Dilation Catheter)
    K Number
    K232245
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jiangsu Vedkang Medical Science and Technology Co., Ltd.
    Date Received
    July 28, 2023
    Decision Date
    February 15, 2024
    Product Code
    FGE
    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
    FGE Stents, Drains And Dilators For The Biliary Ducts

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    Other Clearances by Jiangsu Vedkang Medical Science and Technology Co., Ltd.

    K Number Device Name
    K232825 Disposable Sphincterotome
    K232752 Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)
    K230598 Stone Extraction Baskets
    K222146 Disposable Endoscopic Hemoclip
    K220089 Disposable Polyp Snare
    K213914 Injection Needle