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510(k) Data Aggregation

    K Number
    K200228
    Device Name
    ClearCam System
    Manufacturer
    Date Cleared
    2020-02-19

    (20 days)

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

    ClearCam, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ClearCam System is indicated to provide lens clearing during laparoscopic procedures.
    Device Description
    The ClearCam System is a laparoscopic accessory lens clearing device consisting of a sheath and handle that slides over the laparoscope. The handle contains a wire connected to a wiper at the distal end of the sheath that provides lens clearing when activated. The device is intended to clear the intra-operative view of the surgical site during minimally invasive surgery by physically removing debris, blood, and bodily fluids from the laparoscope lens.
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