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510(k) Data Aggregation

    K Number
    K241796
    Device Name
    TroCare TroKit Laparoscope Lens Wiper (CP000626)
    Manufacturer
    Date Cleared
    2024-10-04

    (105 days)

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

    TroCare, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TroKit Laparoscope Lens Wiper is a laparoscopic accessory lens cleaning device intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding and wiping the laparoscope lens from debris, grease, blood, and bodily fluids. The access device is compatible with the da Vinci Si Surgical System.
    Device Description
    The TroKit Laparoscope Lens Wiper is a sterile, single-use and disposable laparoscopic accessory device that fits onto the distal end of a trocar and with its lens wiper serves to clean the camera lens from blood, tissue, fog, grease, and other surgical debris. The lens wiper itself is a mechanical device within the TroKit that employs a thermoplastic elastomer squeegee. The TroKit is translucent. When the laparoscopic camera is inserted through the trocar into the TroKit its insertion opens the mechanical jaws that house the lens wiper. The wiping is done automatically upon the passage of the laparoscopic camera through the TroKit jaws. The TroKit can be activated and used multiple times during surgery. One device is adequate for one surgery.
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