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510(k) Data Aggregation

    K Number
    K183171
    Device Name
    ScopeSeal Duodenoscope Protective Device
    Manufacturer
    GI Scientific LLC
    Date Cleared
    2019-10-08

    (326 days)

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

    GI Scientific LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    When properly installed: (i) the ScopeSeal® Duodenoscope Protective barrier at the scope's distal end to significantly reduce the level of contamination of the distal end during use and prior to reprocessing, and (ii) the ScopeSeal®'s working channel also provides a protective barrier sealing the duodenoscope's elevator area during use, and (iii) the ScopeSeal® device provides an additional protective benefit after use when kept in place during the ScopeSeal Pre-Cleaning Procedure™ performed after use. The ScopeSeal® is compatible for use with the Olympus Duodenoscope Model TJF-Q180V.
    Device Description
    The GI Scientific ScopeSeal® Duodenoscope Protective Device is provided as a sterile, single-use device that attaches to the distal end of a duodenoscope. When properly installed the device creates a protective barrier or shield that seals the distal end of the duodenoscope to protect it from contamination during the procedure. The device is designed to preserve the mechanical and optical functionality of the duodenoscope. The ScopeSeal® Duodenoscope Protective Device includes a flexible Working Channel Extension™ that seals against the end of the duodenoscope's working channel, providing a sealed, passageway from the end of the duodenoscope's working channel through the ScopeSeal® device's working channel extension and out to the patient's gastrointestinal tract. This element of ScopeSeal®'s design allows instruments to be passed down the duodenoscope's working channel, through the ScopeSeal® device's Working Channel Extension™, and out to the patient's gastrointestinal tract, without instruments coming into contact with the duodenoscope's elevator, effectively sealing over the elevator area of the duodenoscope. The ScopeSeal® allows passage of device up to 10.7Fr (3.5mm) in diameter.
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    K Number
    K140295
    Device Name
    GIS ENDOSCOPIC OPTICAL LENS
    Manufacturer
    GI SCIENTIFIC LLC
    Date Cleared
    2014-07-24

    (168 days)

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

    GI SCIENTIFIC LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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