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510(k) Data Aggregation

    K Number
    K213860
    Device Name
    ArthroFree Wireless Surgical Camera System
    Date Cleared
    2022-03-23

    (103 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Lazurite Holdings LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ArthroFree System is indicated for use in arthroscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery or wherever a laparoscope is indicated for use. The users of the camera are general surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, neurosurgeons and urologists. The ArthroFree System is indicated for use in diagnostic and operative endoscopic procedures, supplying illumination and visualization of an interior cavity of the body. Examples of common general endoscopic surgeries are listed below. - · laparoscopic cholecystectomy - · laparoscopic hernia repair - · laparoscopic appendectomy - laparoscopic pelvic lymph node dissection - · laparoscopically assisted hysterectomy - · laparoscopic and thorascopic anterior spinal fusion - anterior cruciate ligament reconstruction - · knee arthroscopy - · shoulder arthroscopy - small joint arthroscopy - · decompression fixation - · wedge resection - · lung biopsy - · pleural biopsy - · dorsal sympathectomy - · pleurodesis - · internal mammary artery dissection for coronary artery bypass - coronary artery bypass grafting where endoscopic visualization is indicated - · examination of the evacuated cardiac chamber during performance of valve replacement
    Device Description
    The ArthroFree System is a high-definition wireless camera system intended to transmit live video from a surgical site to a patient data console and surgical display during endoscopic surgical procedures. The ArthroFree System also enables the capture of still images and video from the live video stream by transmitting instructions for such capture to a patient data console when indicated by the user. The ArthroFree System is indicated for use in diagnostic and operative endoscopic procedures, supplying illumination and visualization of an interior cavity of the body.
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