Search Filters

Search Results

Found 2 results

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.
    Ask a Question
    K Number
    K190190
    Device Name
    WV1 Endoscope
    Manufacturer
    270Surgical Ltd
    Date Cleared
    2019-11-01

    (273 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 WV1 endoscope is a reusable, rigid, video endoscope, designed to be used with a video system center, light source, 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 WV1 System is comprised of two main components: WV1 endoscope (Video endoscope) and FuseBox (Video Processor, cleared under (K132839). The WV1 endoscope is a reusable, rigid, video endoscope. The device has been designed to be used with a compatible video system, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery. 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 after each use. The WV1 endoscope main components are the distal tip, the endoscope body and the endoscope main connector. 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 a video signal produced by the CCD (Charge Couple Device). The video assembly that controls the field view and image characteristics, including video resolution and brightness, is located in the endoscope's distal tip. The WV1 Distal Tip is equipped with a color CCD and covers a 90° field of view. The extended field of view is achieved by use of additional 2 lenses located behind the endoscope's distal tip, each attached to a separate CCD. The geometrical location of the lenses allows for image overlap that results in the extended field of view (enabled by operation of the Fusebox). Each view on the distal tip has its own dedicated illumination source (LEDs). The images are presented side by side on a display monitor.
    Ask a Question

    Page 1 of 1