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

    Remanufactured EndoWrist ProGrasp Forceps (420093)

    K Number: K241872 · Decision Nov 7, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    7
    Applicant Total
    5
    Review Days
    133

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    Basic Information

    Device Name
    Remanufactured EndoWrist ProGrasp Forceps (420093)
    K Number
    K241872
    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
    June 27, 2024
    Decision Date
    November 7, 2024
    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

    Similar 510(k) Clearances

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

    Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)

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    Remanufactured EndoWrist Cobra Grasper (420190)

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    Remanufactured EndoWrist Cadiere Forceps (420049)

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    FDA Class 2 ·Gastroenterology, Urology

    Remanufactured EndoWrist Tenaculum Forceps (420207)

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    Remanufactured EndoWrist Long Tip Forceps (420048)

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    8mm Monopolar Curved Scissors (470179)

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    Other Clearances by Rebotix

    K Number Device Name
    K250417 Remanufactured EndoWrist Cobra Grasper (420190)
    K250399 Remanufactured EndoWrist Cadiere Forceps (420049)
    K250539 Remanufactured EndoWrist Tenaculum Forceps (420207)
    K250387 Remanufactured EndoWrist Long Tip Forceps (420048)