BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    SB Knife Jr2 (MD-47702 and MD-47702L)

    K Number: K241855 · Decision Mar 26, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    187
    Applicant Total
    5
    Review Days
    272

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    Basic Information

    Device Name
    SB Knife Jr2 (MD-47702 and MD-47702L)
    K Number
    K241855
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sb-Kawasumi Laboratories, Inc.
    Date Received
    June 27, 2024
    Decision Date
    March 26, 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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