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510(k) Data Aggregation

    K Number
    K032688
    Device Name
    COLONOSIGHT MODEL 510B
    Manufacturer
    SIGHTLINE TECHNOLOGIES LTD.
    Date Cleared
    2004-03-05

    (189 days)

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

    SIGHTLINE TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ColonoSight Model 510B is intended to provide visualization (via a video monitor) and therapeutic access to the lower gastrointestinal tract. The lower gastrointestinal tract includes, but is not restricted to, the organs, tissues, and subsystems of the large bowel. The device is introduced rectally as with any standard colonoscope, when indications consistent with the requirement for the procedure are observed in adult patient populations.
    Device Description
    The ColonoSight is a colonoscope covered with a disposable protective sheath and incorporating disposable channels for protective oncain and suction/therapeutic interventions. Intubation, is perfomed using an "air assisted push technology". The main components are: EndoSight, Camera Contol Unit, Hydro-The main componentie t; disposable ColonoSleeve and disposable Hub.
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    K Number
    K011825
    Device Name
    RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE
    Manufacturer
    SIGHTLINE TECHNOLOGIES LTD.
    Date Cleared
    2001-07-11

    (30 days)

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

    SIGHTLINE TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RectoSight® RS300-04 device is a video sigmoidoscope device intended to provide optical visualization of, and therapeutic access to the rectal cavity. The instrument contains channels for insufflation, irrigation and surgical procedures. The ProctoSight® PS310-04 device is a video sigmoidoscope device intended to provide optical visualization of, and therapeutic access to the rectal cavity. The instrument contains channels for insufflation, irrigation and surgical procedures.
    Device Description
    Not Found
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    K Number
    K994130
    Device Name
    RECTOSIGHT RS 300-04
    Manufacturer
    SIGHTLINE TECHNOLOGIES LTD.
    Date Cleared
    2000-06-30

    (206 days)

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

    SIGHTLINE TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RectoSight® RS 300-04 is a video sigmoidoscope device intended to provide optical visualization of, and therapeutic access to the rectal cavity. The instrument contains channels for insufflation, irrigation and surgical procedures. The ProctoSight® PS 300-04 is a video sigmoidoscope device intended to provide optical visualization of, and therapeutic access to the anal cavity. The instrument contains channels for insufflation, irrigation and surgical procedures.
    Device Description
    Not Found
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