BEUDAMED
    Product Code: QSM FDA class 2 21 CFR 876.1500

    System, Surgical, Computer Controlled Instrument, Remanufactured

    Gastroenterology, Urology

    The Remanufactured Computer-Controlled Surgical Instrument System is a computer-controlled surgical system that has been remanufactured and is intended for use consistent with the originally cleared device's intended purpose. Remanufacturing involves restoring the device to its original specifications for reuse. Classified as FDA Class 2 under regulation 876.1500, it requires 510(k) clearance and falls under the Gastroenterology and Urology specialty. The device is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    8
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    3
    Years Active
    3

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    Basic Information

    Product Code
    QSM
    Device Class
    FDA class 2
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    As intended with the originally cleared instrument.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 8 510(k) clearances via K numbers.

    K Number Device Name
    K252926 Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)
    K250417 Remanufactured EndoWrist Cobra Grasper (420190)
    K250539 Remanufactured EndoWrist Tenaculum Forceps (420207)
    K250399 Remanufactured EndoWrist Cadiere Forceps (420049)
    K250387 Remanufactured EndoWrist Long Tip Forceps (420048)
    K242610 8mm Monopolar Curved Scissors (470179)
    K241872 Remanufactured EndoWrist ProGrasp Forceps (420093)
    K210478 8mm Monopolar Curved Scissors

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.