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510(k) Data Aggregation

    K Number
    K181418
    Device Name
    ScopeFlow Pure(TM)
    Date Cleared
    2019-07-11

    (406 days)

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

    Partnership Medical Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ScopeFlow Pure™ is intended to be used in in conjunction with a flexible endoscope to insufflate air/CO2 and supply sterile water during endoscopic procedures. The ScopeFlow Pure™ is compatible with the different sterile water bottles available. It is intended to be used for 24 hours and then disposed of.
    Device Description
    The ScopeFlow Pure™ is used to convey sterile water from an external water source to a flexible endoscope to aid its function. The ScopeFlow Pure™ consists of: 1) PVC tubing is used provide the method of transferring the sterile water from the external source to the flexible endoscope. This sterile water is used to clean the lens of the flexible endoscope during operation or to assist in improving the flexible endoscopes visual field. 2) An endoscope connector at the distal end of the device. For the ScopeFlow Pure™ the three different connectors are designed to fit Olympus, Pentax and Fujinon endoscopes. The connectors are manufactured from medical grade plastic, which is used as an outer housing and medical grade TPE or silicone which are used as seals to prevent water and air from escaping during use. The ScopeFlow Pure™ functions by using a two parallel tubes configuration to supply air to the water bottle and provide water to the flexible endoscope. The HYBRID configuration consists of the ScopeFlow Pure™ and an EndoStream™ units being used together. The HYBRID models function in the same way but instead of using a separate sterile bottle for irrigation of the lens and irrigation of the GI Tract, one bottle of sterile water is used as the feed for both, the Hybrid has only one screwcap.
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    K Number
    K181457
    Device Name
    EndoStream(TM)
    Date Cleared
    2019-07-11

    (402 days)

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

    Partnership Medical Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EndoStream™ tubing is intended to provide irrigation via sterile water supply during gastrointestinal (GI) endoscopic procedures when used in conjunction with an irrigation pump.
    Device Description
    The EndoStream™ is available in two (2) configurations: PFE130 and PFE230. The EndoStream™ is used to convey sterile water from an external water source to a flexible endoscope to aid its function. This sterile water is used to clean the lens of the flexible endoscope during operation or to assist in improving the flexible endoscopes visual field. The device consists of PVC tubing and an endoscope connector with a medical grade plastic check valve. It functions by using a single lumen in conjunction with a peristaltic pump to provide water to the flexible endoscope. EndoStream™ connects a sterile water supply into the proximal end of an endoscope. Once connected, EndoStream™ allows sterile water to flow into the endoscope which carries it into the Gastrointestinal (GI) tract to flush out the GI tract during endoscopic procedures. It is a tubing with a cap which directly screws onto a sterile water bottle. The tubing extremity connects to the endoscope via the pump head on a peristaltic irrigation pump. A back flow valve is integrated in the extremity of each EndoStream™ tubing ensuring the unidirectional flow from the sterile water bottle to the endoscope, thus guaranteeing the prevention of risks of cross contamination.
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