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510(k) Data Aggregation

    K Number
    K221824
    Device Name
    OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), Contd from 3 above: CS-05-00-300, CS-05-30-300, CS-05-00-315, CS-05-30-315
    Date Cleared
    2022-08-19

    (57 days)

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

    Cipher Surgical Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OpClear® Platform consists of a reusable control unit and a range of disposable sterile single-use accessories intended to remove visual obstructions on the distal window of laparoscopes, such as condensation, blood and other tissue particulates, therefore maintaining a clear image of the surgical site. The OpClear ®Platform is indicated for use in abdominal laparoscopy.
    Device Description
    OpClear® Platform 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® Platform is composed of a control unit and a range of disposable accessories as shown below. | Description | Part Number | |--------------------------------------|-------------| | OpClear Control Unit with footswitch | CS-CU33 | #### OpClear® Disposables | OpClear Part # | Diameter | Angle | Working<br>Length | |----------------|----------|-----------|-------------------| | CS-10-00-300 | 10 mm | 0° | 300 mm | | CS-10-30-300 | 10 mm | 30° / 45° | 300 mm | | CS-10-00-315 | 10 mm | 0° | 315 mm | | CS-10-30-315 | 10 mm | 30° / 45° | 315 mm | | CS-10-00-330 | 10 mm | 0° | 330 mm | | CS-10-30-330 | 10 mm | 30° / 45° | 330 mm | | CS-05-00-290 | 5 mm | 0° | 290mm | | CS-05-30-290 | 5 mm | 30° / 45° | 290mm | | CS-05-00-300 | 5 mm | 0° | 300mm | | CS-05-30-300 | 5 mm | 30° / 45° | 300mm | | CS-05-00-315 | 5 mm | 0° | 315mm | | CS-05-30-315 | 5 mm | 30° / 45° | 315mm |
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