Search Filters

Search Results

Found 8 results

510(k) Data Aggregation

    K Number
    K223183
    Device Name
    Light-Guide Cables
    Manufacturer
    Olympus Winter & Ibe GmbH
    Date Cleared
    2023-01-13

    (93 days)

    Product Code
    HBI
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    HBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Transmission of light energy from the light source to an optical instrument. The light-guide cable is used to transmit light during endoscopic procedures or for other medical illumination application when the properties and operating instructions are complied with. The light-guide cable is designed for use with halogen, xenon or LED based light which are utilized in medical applications that involve endoscopes, medical instruments or microscopes.
    Device Description
    The Olympus Light-Guide Cables that are subject to this submission are intended to transmit light from the light source to an optical instrument. For that purpose the Light-Guide Cable includes a bundle of optical fibers as transmission medium. The light guide adapters are intended for the mechanical connection of the Light-Guide Cables to light sources or to endoscopes. There are two variants of Light-Guide Cables which differ according to the shaft diameter of the connected endoscope. Cable WA03300A (2.8 mm, 3 m, CF type) can be combined with endoscopes, which have a diameter ≤ 4.1mm. Endoscopes with a diameter > 4.1mm are combined with WA03310A (4.25 mm, 3 m, CF type). Otherwise the Light-Guide Cables are identical.
    Ask a Question
    K Number
    K163185
    Device Name
    OptiLux LED Illuminator
    Manufacturer
    ISOLUX LLC
    Date Cleared
    2016-11-21

    (7 days)

    Product Code
    HBI
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    HBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Isolux Ilc OptiLux LED Illuminator is indicated for use in transmitting light for illumination purposes from an LED source via a fiber optic cable and attached to either an endoscope, surgical head light or other tools that contain in providing illumination to body cavities during examinations or surgical procedures.
    Device Description
    Not Found
    Ask a Question
    K Number
    K141781
    Device Name
    KOGENT SPETZLER LIGHTED SUCTION TUBES
    Manufacturer
    KATALYST SURGICAL, LLC
    Date Cleared
    2015-04-09

    (281 days)

    Product Code
    HBI, FST
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    HBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kogent™ Spetzler Lighted Suction Tubes are intended to provide surgical site illumination from a high intensity light source.
    Device Description
    This device is a disposable Kogent™ Spetzler Lighted Suction Tubes, designed for single use in surgical procedures. Lighted Suction Tubes require connection with a suitable operating room suction system to deliver suction as well as with a suitable illumination machine. Lighted Suction Tubes are designed to provide illumination while having the ability to aspirate the surgical site. The devices are provided sterile by Ethylene Oxide and in sterile packaging.
    Ask a Question
    K Number
    K111342
    Device Name
    LIGHT GUIDE CABLE
    Manufacturer
    SCHOTT NORTH AMERICA
    Date Cleared
    2011-11-25

    (196 days)

    Product Code
    HBI
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    HBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Schott Light Guide Cable is indicated for use in transmitting light for illumination purposes from an illuminator to various instruments such as headlights, microscopes and endoscopes, providing illumination in body cavities during examinations or surgical procedures.
    Device Description
    The Light guide cable consists of glass fibers which are glued or fused into ferrules on both ends. The ends are polished to effectively transmit light and are equipped with standard endoscope connectors to transmit visible light from the light source to the intended instrument. The fibers are covered by Silicone sheathing for ease of handling and protecting the fibers from damage. The device is intended to be Ethylene Oxide (EtO) sterilized by the user. Sterilization information is contained in section 14.
    Ask a Question
    K Number
    K052979
    Device Name
    1125 XSB XENON FIBER-OPTIC LIGHT SOURCE
    Manufacturer
    ISOLUX LLC
    Date Cleared
    2005-10-31

    (7 days)

    Product Code
    HBI
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    HBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K021931
    Device Name
    ENDOSCOPIC FIBEROPTIC CABLE
    Manufacturer
    GULF MEDICAL FIBEROPTICS
    Date Cleared
    2002-09-06

    (86 days)

    Product Code
    HBI, FFS
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    HBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endoscopic Fiberoptic Cable is used to conduct visible light from a light source to an endoscope during a surgical procedure.
    Device Description
    Endoscopic Fiberoptic Cable
    Ask a Question
    K Number
    K991208
    Device Name
    ENDOSCOPIC FIBEROPTIC CABLE
    Manufacturer
    ISOLUX AMERICA
    Date Cleared
    1999-06-23

    (75 days)

    Product Code
    HBI
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    HBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ISOLUX America's fiber optic cable is indicated for use in transmitting light for illumination purposes from an illuminator to various instruments such as headlights, microscopes and endoscopes, providing illumination in body cavities during examinations or surgical procedures.
    Device Description
    Fiberoptic Cable
    Ask a Question
    K Number
    K983277
    Device Name
    LIGHTSOURCE OR ILLUMINATOR MODEL I-100
    Manufacturer
    CUDA PRODUCTS CO.
    Date Cleared
    1998-12-16

    (90 days)

    Product Code
    HBI, FCR, FCW, FFS, HET
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    HBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: lightsource attaches to fiberoptic cable which is then attached to a headlight or microscope or video camera. The lightsource supplies light for the headlight or microscope or video camera.
    Device Description
    Lightsource or illuminator I-100
    Ask a Question

    Page 1 of 1