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

    Disposable Sphincterotome

    K Number: K232476 · Decision Nov 7, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    187
    Applicant Total
    5
    Review Days
    83

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Disposable Sphincterotome
    K Number
    K232476
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zhejiang Soudon Medical Technology Co., Ltd.
    Date Received
    August 16, 2023
    Decision Date
    November 7, 2023
    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)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KNS), ordered by most recent decision date.

    Sphincterotome

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Vanquish Water Vapor Ablation Device

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SureTome™ SW Sphincterotome with DomeTip

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

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

    K Number Device Name
    K253013 Disposable Stone Retrieval Balloon Catheter
    K253056 Disposable Stone Extraction Basket
    K232450 Disposable Hemostatic Clips
    K232442 Disposable Endoscope Injection Needles