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510(k) Data Aggregation

    K Number
    K171637
    Device Name
    OpClear System
    Manufacturer
    Cipher Surgical Ltd
    Date Cleared
    2018-02-26

    (269 days)

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

    Cipher Surgical Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OpClear® System consists of a reusable control unit and a range of disposable sterile single-use accessories intended to remove visual obstructions such as condensation, blood and other tissue particulates from the distal lens of a laparoscope during surgery and therefore maintaining a clear image of the surgical site.
    Device Description
    OpClear® System is a laparoscopic lens cleaning device which is intended to be used during any laparoscopic surgical procedure where there is a potential for contamination of the distal lens. Consisting of a reusable control unit and a range of sterile, invasive, single use disposables, it is intended to maintain surgical vision by removing contaminants such as condensation, blood, peritoneal fluid, smoke, fat and tissue smears that have contaminated the distal lens of the laparoscope during surgical procedures. OpClear® System is composed of a control unit and a range of disposable accessories as shown below.
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