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

    Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR

    K Number: K251807 · Decision Mar 6, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    45
    Applicant Total
    102
    Review Days
    267

    Basic Information

    Device Name
    Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR
    K Number
    K251807
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Medical Systems Corp.
    Date Received
    June 12, 2025
    Decision Date
    March 6, 2026
    Product Code
    KGE
    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
    KGE Forceps, Biopsy, Electric

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