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Found 8 results
510(k) Data Aggregation
K Number
K223183Device Name
Light-Guide Cables
Manufacturer
Olympus Winter & Ibe GmbH
Date Cleared
2023-01-13
(93 days)
Product Code
HBI
Regulation Number
878.4580Why 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.
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K Number
K163185Device Name
OptiLux LED Illuminator
Manufacturer
ISOLUX LLC
Date Cleared
2016-11-21
(7 days)
Product Code
HBI
Regulation Number
878.4580Why 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
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K Number
K141781Device Name
KOGENT SPETZLER LIGHTED SUCTION TUBES
Manufacturer
KATALYST SURGICAL, LLC
Date Cleared
2015-04-09
(281 days)
Product Code
HBI, FST
Regulation Number
878.4580Why 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.
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K Number
K111342Device Name
LIGHT GUIDE CABLE
Manufacturer
SCHOTT NORTH AMERICA
Date Cleared
2011-11-25
(196 days)
Product Code
HBI
Regulation Number
878.4580Why 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.
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K Number
K052979Device Name
1125 XSB XENON FIBER-OPTIC LIGHT SOURCE
Manufacturer
ISOLUX LLC
Date Cleared
2005-10-31
(7 days)
Product Code
HBI
Regulation Number
878.4580Why did this record match?
Product Code :
HBI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K021931Device Name
ENDOSCOPIC FIBEROPTIC CABLE
Manufacturer
GULF MEDICAL FIBEROPTICS
Date Cleared
2002-09-06
(86 days)
Product Code
HBI, FFS
Regulation Number
878.4580Why 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
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K Number
K991208Device Name
ENDOSCOPIC FIBEROPTIC CABLE
Manufacturer
ISOLUX AMERICA
Date Cleared
1999-06-23
(75 days)
Product Code
HBI
Regulation Number
878.4580Why 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
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K Number
K983277Device 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
878.4580Why 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
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