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510(k) Data Aggregation

    K Number
    K200874
    Device Name
    TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End
    Manufacturer
    Innovasis, Inc.
    Date Cleared
    2020-06-30

    (90 days)

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

    FST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TruView Light Cable is intended to provide surgical site illumination from a fiber optic light source.
    Device Description
    The TruView Light Cable is a fiber optic surgical light designed to be compatible with a variety of fiber optic light sources.
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    K Number
    K141330
    Device Name
    ENDO-CORD
    Manufacturer
    ENROXTECH, INC.
    Date Cleared
    2014-12-15

    (208 days)

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

    FST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to transmit light for illumination purposes from the light source to endoscopes.
    Device Description
    A 5mm fiber-optic light transmitting core with durable protective sleeve and stainless steel couplings at each end. One coupling is for the light source and the opposite end for connection to an endoscope. The core is inserted into a durable and reusable silicone rubber sheath. One length is available: 7.5 Feet. Field replaceable fiber-optic core.
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    K Number
    K122637
    Device Name
    LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999
    Manufacturer
    STRYKER SPINE
    Date Cleared
    2012-11-01

    (64 days)

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

    FST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stryker Spine LITe® Decompression System - Light Cable is intended to provide surgical site illumination from a high intensity light source when Stryker decompression tubes are in use.
    Device Description
    The Stryker Spine LITe® Decompression System - Light Cable is a single use, sterile and disposable component. The Stryker Spine LITe® Decompression System - Light Cable consists of fiber optic cables contained within silicone tubing which can be connected to a light generator on one end and the tube of the Stryker Spine LITe® Decompression System on the other end.
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    K Number
    K113697
    Device Name
    EIGR SURGICAL ILLUMINATION SYSTEM
    Manufacturer
    INVUITY, INC.
    Date Cleared
    2012-02-10

    (56 days)

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

    FST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Invuity® Eigr™ Surgical Illumination System is intended to provide surgical site illumination from a high intensity light source.
    Device Description
    Not Found
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    K Number
    K113330
    Device Name
    CABLECAP
    Manufacturer
    SENSORMED
    Date Cleared
    2012-01-12

    (59 days)

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

    FST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device absorbs and diffuses the light transmitted through the cable in order to prevent patient burns and igniting flammable items in the surgical suite.
    Device Description
    The CableCap device attaches to the distal end of high intensity light cables. The device absorbs and diffuses the light transmitted through the cable in order to prevent patient burns and igniting flammable items in the surgical suite. There are three separate models made for the three types of light cables:
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    K Number
    K102266
    Device Name
    ISOLED AC-POWERED LED HEADLIGHT SYSTEM
    Manufacturer
    ISOLUX LLC
    Date Cleared
    2010-09-24

    (45 days)

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

    FST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Headlight is indicated for use in transmitting illumination to a body cavity or surgical procedure.
    Device Description
    Not Found
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    K Number
    K101496
    Device Name
    CABLECAP MODEL: WLF, STZ, ACM
    Manufacturer
    SENSORMED
    Date Cleared
    2010-09-14

    (105 days)

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

    FST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CableCap device attaches to the distal end of high intensity light cables. The device absorbs and diffuses the light transmitted through the cable in order to prevent patient burns and igniting flammable items in the surgical suite. It is necessary to check each light cable to determine which CableCap model (STZ, ACM, WLF) to use. See product instructions for cleaning and sterilization protocols. The device is not intended to be used to illuminate the surgical field.
    Device Description
    The CableCap device attaches to the distal end of high intensity light cables. The device absorbs and diffuses the light transmitted through the cable in order to prevent patient burns and igniting flammable items in the surgical suite. There are three separate models made for the three types of light cables: WLF, STZ, ACM.
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    K Number
    K100388
    Device Name
    21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS
    Manufacturer
    MEDICAL ILLUMINATION INTERNATIONAL, INC.
    Date Cleared
    2010-06-22

    (126 days)

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

    FST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 21tt Century Centurion ExceLED and System Two LED lights are intended to provide visible illumination of the surgical field and the patient during surgical and non surgical procedures. The System Two LED surgical Lighting System is an AC powered device which provides a focusable filed of illumination for general examination and surgery. It can consist of any combination of the 3 lights (D1, D2, D3) listed below. All 3 models will have 5-level dimming and beam size (8"-12") adjustments. D1 = small minor surgical light / satellite - D2 = large minor surgical light D3 = major surgical light
    Device Description
    The proposed 21* Century Centurion ExceLED (an AC powered device) is the first generation fixed pattern / five level intensity minor surgical LED (Light Emitting Diode) light designed to provide visible illumination of the surgical field and the patient during minor surgical and non-surgical procedures. The proposed System Two LED surgical Lighting System is an AC powered device which provides a focusable field of illumination for general examination and surgery. It can consist of any combination of the 3 lights (D1, D2, D3) listed below. All 3 models will have 5-level dimming and beam size (8"-12") adjustments. - D1 = small minor surgical light / satellite - D2 = large minor surgical light - D3 = major surgical light
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    K Number
    K100395
    Device Name
    HARMONY VLED SURGICAL LIGHTNING SYSTEM
    Manufacturer
    STERIS Corporation
    Date Cleared
    2010-03-17

    (29 days)

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

    FST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Harmony vLED Surgical Lighting System is a variable pattern / intensity surgical light designed to provide visible illumination of the surgical field and the patient and to provide video-visual procedural support for the hospital staff during surgical procedures.
    Device Description
    The Harmony vLED Surgical Lighting System is a variable pattern / intensity surgical light designed to provide visible illumination of the surgical field and the patient and to provide video-visual procedural support for the hospital staff during surgical procedures. The Harmony vLED Surgical Lighting System is designed to replace existing surgical lights, or to be installed as part of major renovations to existing facilities or in new facilities. The Harmony vLED Surgical Lighting System accessories are as follows: - STERIS ACT Interface o - o Camera Module - Dual or Single Flat Panel Monitors o - o 24VDC Battery Backup support - Remote Power Module Unit 0 - Sterile Disposable Handle Covers o
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    K Number
    K093386
    Device Name
    CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST
    Manufacturer
    BFW, INC
    Date Cleared
    2010-01-28

    (90 days)

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

    FST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ChromaLUME Turbo Light Source is designed for use with fiber optic headlight systems to supply high intensity light through the fiber optic cable for illumination of a surgical field. The ChromaLUME Turbo Light Source will accommodate fiber optic cables from Wolf, Storz, Olympus and ACMI/BFW products. The XtremeBeam Fiber Optic Headlamp is a passive luminary which is illuminated by the fiber optic light to provide supplemental light for surgical procedures.
    Device Description
    The ChromaLUME Turbo Light Source is designed for use with fiber optic headlight systems. Its' intended function and use is to supply high intensity light through the fiber optic cable for illumination of a surgical field. The ChromaLUME Turbo Light Source will accommodate fiber optic cables from Wolf, Storz, Olympus and ACMI/BFW products. The XtremeBeam Fiber Optic Headlight is a passive luminary which is illuminated by the fiber optic light to provide supplemental light for surgical procedures. It is constructed of a durable plastic housing, lenses, spot size adjustment, and positioning bar. It utilizes a proprietary fiber optic cable, the distal end of which will fit an ACMI port. The luminaire optics consist of optic lenses, a mirror, and an iris.
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