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510(k) Data Aggregation

    K Number
    K242417
    Device Name
    VECTR – Video Endoscopic Carpal Tunnel Release System
    Manufacturer
    Rafael Medical Devices, LLC
    Date Cleared
    2024-12-11

    (118 days)

    Product Code
    HRX, EMF
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rafael Medical Devices, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VECTR - Video Endoscopic Carpal Tunnel Release System is in minimally invasive ligament or fascia release surgeries, such as: · Carpal tunnel release in the wrist · Cubital tunnel release in the elbow
    Device Description
    The VECTR – Video Endoscopic Carpal Tunnel Release System is composed of a handpiece (5200-01) and a proprietary tablet (5200-90). The handpiece is an arthroscopic unit with an integrated surgical knife. It is intended for minimally invasive ligament or fascia release in endoscopic carpal tunnel release (ECTR) surgery. The proprietary tablet is a registered class I medical device that is commercially available. The handpiece is a single-use disposable device that combines the traditional manual surgical knife with an arthroscope all in one. It is fully integrated into a single unit and consists of a functional tip (surgical knife), live-action camera, light, cannula, and cord to connect to the proprietary tablet. The surgical knife can be used to sever tendons, ligaments, or fascia in the joints or limbs and is able to be protracted or retracted via a slide switch on the side of the handpiece. During procedures, surgeons will introduce the device through incisions made in the patient's wrist. Once inside, the camera and light are used to visualize the surgical environment on the proprietary tablet. Once the surgeon has maneuvered the device into the desired location, the blade can be actuated and the ligament can be cut. Once cut, the surgeon will withdraw the blade and remove the device.
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