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

    Disposable Sphincterotome

    K Number: K232825 · Decision Mar 29, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    187
    Applicant Total
    7
    Review Days
    198

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    Basic Information

    Device Name
    Disposable Sphincterotome
    K Number
    K232825
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jiangsu Vedkang Medical Science and Technology Co., Ltd.
    Date Received
    September 13, 2023
    Decision Date
    March 29, 2024
    Product Code
    KNS
    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
    KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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    FDA 510(k)
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    Other Clearances by Jiangsu Vedkang Medical Science and Technology Co., Ltd.

    K Number Device Name
    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)
    K232245 VedDilator ^TM (3-Stage Balloon Dilation Catheter)
    K230598 Stone Extraction Baskets
    K222146 Disposable Endoscopic Hemoclip
    K220089 Disposable Polyp Snare
    K213914 Injection Needle