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

    Disposable Sphincterotome

    K Number: K242192 · Decision Feb 6, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    187
    Applicant Total
    6
    Review Days
    195

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    Basic Information

    Device Name
    Disposable Sphincterotome
    K Number
    K242192
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beijing Zksk Technology Co., Ltd.
    Date Received
    July 26, 2024
    Decision Date
    February 6, 2025
    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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    Other Clearances by Beijing Zksk Technology Co., Ltd.

    K Number Device Name
    K231721 Disposable Hot Biopsy Forceps
    K213217 Disposable hemoclip
    K213222 Disposable Polypectomy Snare
    K213223 Multi-Band Ligator
    K213239 Endoscopic Injection Needle