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510(k) Data Aggregation

    K Number
    K024251
    Device Name
    SIGHTFIX
    Manufacturer
    WORLD OF MEDICINE LEMKE GMBH
    Date Cleared
    2003-03-18

    (85 days)

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

    WORLD OF MEDICINE LEMKE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SightFix is intended to allow access and observation of body cavities and the surgical field during diagnostic and therapeutic procedures in laparoscopy and open surgery.
    Device Description
    The SightFix consists of a rigid endoscope and a flexible holding arm. The rigid endoscope of the SightFix contains an optic and a light fiber. The SightFix endoscope is designed to be used with the camera SightCam and the light source SightLight manufactured by WORLD OF MEDICINE Lemke GmbH. In addition, the use of adapters allows an easy attachment of standard 180W endoscopic light sources (halogen, xenon, quartz) to the endoscope. The holding arm of the SightFix is a manually operated endoscope holder to ensure an optimal positioning of the endoscope. Both the rigid endoscope and some components of the holding arm are autoclavable.
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    K Number
    K023468
    Device Name
    ENDOSCOPIC LIGHT SOURCE XL180/L3
    Manufacturer
    WORLD OF MEDICINE LEMKE GMBH
    Date Cleared
    2003-01-14

    (90 days)

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

    WORLD OF MEDICINE LEMKE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endoscopic Light Source XL180/L3 is intended to be used with fiber optic endoscopes to provide illumination of body cavities, hollow organs and canals during endoscopic procedures.
    Device Description
    The Endoscopic Light Source XL180/L3 uses a 180 W xenon lamp to provide illumination during endoscopic diagnostic and surgical procedures through a fiber optic cable, which is connected to the device. Brightness can be adjusted manually. The color temperature of the xenon lamp is approximately 6000 °K and the lamp life is approximately 500 hours.
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    K Number
    K021717
    Device Name
    ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5
    Manufacturer
    WORLD OF MEDICINE LEMKE GMBH
    Date Cleared
    2002-08-20

    (89 days)

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

    WORLD OF MEDICINE LEMKE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endoscopic Light Source XL300/L5 is intended to be used with fiber optic endoscopes to provide illumination of body cavities, hollow organs and canals during endoscopic procedures.
    Device Description
    The Endoscopic Light Source XL300/L5 uses a 300 W xenon lamp to provide illumination during endoscopic diagnostic and surgical procedures through a fiber optic cable, which is connected to the device. Brightness can be adjusted manually. The color temperature of the xenon lamp is approximately 5600 °K and the lamp life is approximately 500 hours.
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    K Number
    K021456
    Device Name
    ER150/M2
    Manufacturer
    WORLD OF MEDICINE LEMKE GMBH
    Date Cleared
    2002-08-01

    (87 days)

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

    WORLD OF MEDICINE LEMKE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ER150/M2 is a video monitor intended to display viewable images transmitted by standard video signals during surgical or diagnostic procedures, particularly in endoscopy.
    Device Description
    The ER150/M2 is a color video monitor intended to display viewable medical images transmitted by standard video signals. In particular, the device is intended for use as part of a visualisation system in endoscopic surgery. The monitor accepts and processes composite=FBAS, Y-UV, analog RGB, digital RGB, Y/C signals and NTSC, PAL and SECAM standard video signals. The ER150/M2 is designed with a digital microprocessor and offers an automatic input selection. The received signal is displayed on a 20" screen. The images can be adjusted by the user for color, contrast, hue, brightness, enhanced sharpness and color temperature (6500K or 9300K). Additional output sockets of the ER150/M2 allow the connection to further equipment including a second monitor or recording device.
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    K Number
    K020889
    Device Name
    ENDOSCOPIC LIGHT SOURCE XL202/L3
    Manufacturer
    WORLD OF MEDICINE LEMKE GMBH
    Date Cleared
    2002-06-05

    (78 days)

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

    WORLD OF MEDICINE LEMKE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endoscopic Light Source XL202/L3 is intended to be used with fiber optic endoscopes to provide illumination of body cavities, hollow organs and canals during endoscopic procedures. The device is classified as Cardiac Floating (CF) which allows the use in endoscopic cardiac procedures when used in conjunction with the proper instrumentation.
    Device Description
    The Endoscopic Light Source XL202/L3 uses a 180 W xenon lamp to provide illumination during endoscopic surgery through a fiber optic cable, which is connected to the device. Furthermore, the light source can be equipped with an additional 150 W halogen lamp for diagnostic applications in endoscopy. The 150 W halogen lamp also function as a backup up lamp to avoid interrupting a procedure in case of a malfunction of the xenon lamp. The color temperature of the xenon lamp and halogen lamp is approximately 6000 % and 3400 % respectively, the lamp life approximately 500 hours and 50 h respectively.
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    K Number
    K014158
    Device Name
    ENDOSCOPIC CAMERA TC804/C4
    Manufacturer
    WORLD OF MEDICINE LEMKE GMBH
    Date Cleared
    2002-03-14

    (85 days)

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

    WORLD OF MEDICINE LEMKE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endoscopic Camera TC804/C4 is intended to attach to standard endoscopes to permit visualization of body cavities, hollow organs and canals during endoscopic procedures. It also may be attached to a microscope. The endoscopic image can be displayed on any standard video monitor.
    Device Description
    The Endoscopic Camera TC804/C4 is a 3-CCD camera, which consists of a camera control unit (CCU), a camera head, various connecting objectives, cables and adapters. The Endoscopic Camera TC804/C4 takes the image through standard endoscopes that would be normally seen with the naked eye, and displays it on any standard video monitor. The camera head is supplied with a standard 30 mm endofocus objective but may also be used with a 25 mm or zoom objective. The device is programmable by two head key bottons and is equipped with a ring-focus for both right-handed and left-handed users.
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    K Number
    K020336
    Device Name
    ENDOSCOPIC CAMERA MC404/C3
    Manufacturer
    WORLD OF MEDICINE LEMKE GMBH
    Date Cleared
    2002-03-14

    (41 days)

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

    WORLD OF MEDICINE LEMKE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endoscopic Camera MC404/C3 is intended to attach to standard endoscopes to permit visualization of body cavities, hollow organs and canals during endoscopic procedures. It also may be attached to a microscope. The endoscopic image can be displayed on any standard video monitor.
    Device Description
    The Endoscopic Camera MC404/C3 is a 1-CCD camera, which consists of a camera control unit (CCU), a camera head, various connecting objectives, cables and adapters. The Endoscopic Camera MC404/C3 takes the image through standard endoscopes that would be normally seen with the naked eye, and displays it on any standard video monitor. The camera head is supplied with a standard 25 mm endofocus objective but may also be used with a 16 mm, 30 mmm or zoom (f = 13 to 28 mm) objective. The device is programmable by two head key bottons and offers focusing for both right-handed and left-handed users.
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