BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Remanufactured EndoWrist Cobra Grasper (420190)

    K Number: K250417 · Decision Aug 20, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    7
    Applicant Total
    5
    Review Days
    188

    Basic Information

    Device Name
    Remanufactured EndoWrist Cobra Grasper (420190)
    K Number
    K250417
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rebotix
    Date Received
    February 13, 2025
    Decision Date
    August 20, 2025
    Product Code
    QSM
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QSM System, Surgical, Computer Controlled Instrument, Remanufactured

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    Other Clearances by Rebotix

    K Number Device Name
    K250399 Remanufactured EndoWrist Cadiere Forceps (420049)
    K250539 Remanufactured EndoWrist Tenaculum Forceps (420207)
    K250387 Remanufactured EndoWrist Long Tip Forceps (420048)
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