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510(k) Data Aggregation

    K Number
    K210104
    Device Name
    SurroundScope System
    Manufacturer
    270Surgical Ltd.
    Date Cleared
    2021-07-08

    (175 days)

    Product Code
    HET, GCJ
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    270Surgical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SurroundScope System is designed to be used with documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including the female reproductive organs.
    Device Description
    The SurroundScope System (SS) is an endoscopic platform for visualization during surgery. The SS System is a modification of the previously cleared WV1 Endoscope (K190190) developed by 270Surgical. The SS System is designed to be used with documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment. The SS System features two viewing capabilities: standard and extended. The standard view uses one lens and displays a 90 degree field of view while the extended view uses two additional lenses on the side of the tip and displays a 270 degree field of view. Each lens has its own set of LEDs for illumination. The SS System is comprised of two main components: - SS endoscope (Video endoscope) - Camera Controller Unit (CCU) (Video Processor) The SS endoscope is a reusable, rigid video endoscope. It is a reusable (autoclavable) endoscope and is intended to be used in a sterile environment. It is initially supplied non-sterile to the user and requires the user to process (i.e., clean and sterilize) the device for initial use, as well as to reprocess the device after each use. The SS endoscope main components are the video and illumination system, the endoscope body, and the endoscope main connector. The endoscope consists of a camera head at the distal tip, insertion tube, control handle, umbilical cable, and main connector. The insertion tube and distal tip are made of gold coated stainless steel. The distal tip contains sapphire for the optical components. The required illumination for the endoscope is supplied by integrated LEDs, located on the endoscope's distal tip. The endoscope video system is controlled by the video processor which collects the video signal produced by the image sensors (CMOS). The SurroundScope Camera Control Unit (CCU) processes and manages the images/video signal from the endoscope and transfers them to the monitor. The CCU video center also powers and controls the CMOS located in the SS endoscope.
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