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510(k) Data Aggregation

    K Number
    K080809
    Device Name
    IEC MEDSIGHT AND MEDBRIGHT
    Manufacturer
    INNOVATIVE ENDOSCOPY COMPONENTS, LLC.
    Date Cleared
    2008-08-11

    (143 days)

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

    INNOVATIVE ENDOSCOPY COMPONENTS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Innovative Endoscopy Components (IEC) MedSIGHT and MedBRIGHT is a video system for endoscopes. MedSIGHT is a color, television camera system (supplies image) and MedBRIGHT is a xenon/halogen light source system (supplies light). Both can be used with all rigid endoscopes (like Arthroscopes, Cystoscopes, Hysteroscopes, Laparoscopes, Ureterorenoscopes, etc.) and some flexible endoscopes (Sinuscope and Bronchoscope) and it is designed for surgical procedures.
    Device Description
    The Innovative Endoscopy Components (IEC) MedSIGHT and MedBRIGHT is a video system for endoscopes. The IEC MedSIGHT is a endoscopic color camera system and used in a variety of endoscopic surgical procedures (orthopedic, laparoscopic, urologic, sinuscopic, plastic, ... ) to capture and visualize the image from the endoscope on a monitor. The system consists of a control unit and a video head. The cable of the video head connects to the control unit. The video head connects to all rigid endoscopes (like Arthroscopes, Cystoscopes, Hysteroscopes, Laparoscopes, Ureterorenoscopes, etc.) and some flexible endoscopes (Sinuscope and Bronchoscope). The IEC MedBRIGHT is a endoscopic light source system and used with all rigid endoscopes (like Arthroscopes, Cystoscopes, Hysteroscopes, Laparoscopes, Ureterorenoscopes, etc.) and some flexible endoscopes (Sinuscope and Bronchoscope) to provide light for a high visual and photographic clarity for color rendition. The system consists of a control unit and a fiber optic cable. The fiber optic cable connects on one site with the control unit and the other side it connects to the endoscope. All these components are designed, constructed and intended to be operated exclusivelv as a unit.
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    K Number
    K062707
    Device Name
    RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE
    Manufacturer
    INNOVATIVE ENDOSCOPY COMPONENTS, LLC.
    Date Cleared
    2006-12-08

    (88 days)

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

    INNOVATIVE ENDOSCOPY COMPONENTS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992983
    Device Name
    BAHO AUTOCLAVABLE CYSTOSCOPE
    Manufacturer
    INNOVATIVE ENDOSCOPY COMPONENTS, LLC.
    Date Cleared
    1999-10-07

    (34 days)

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

    INNOVATIVE ENDOSCOPY COMPONENTS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Like the predicate devices, the BAHO autoclavable Cystoscope is indicated for use in the visual examination of body cavities, hollow organs and canals and using additional accessories, to perform various diagnostic and therapeutic procedures.
    Device Description
    The BAHO autoclavable Cystoscope has a basic design similar to those legally available for sale in the U.S.A. Like others legally sold in the U.S.A.,it consists of an evepiece.body and insertion tube. The insertion tube is double walled surgical steel with illumination fibers in between. The insertion tube contains the optical rod lens system. ( identical to BAHO autoclavable Laparoscope 510(k) Number K982276 )
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