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510(k) Data Aggregation

    K Number
    K060802
    Device Name
    VISUM LED SURGICAL LIGHTING SYSTEM
    Manufacturer
    STRYKER COMMUNICATIONS CORP.
    Date Cleared
    2006-04-07

    (14 days)

    Product Code
    FSY
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    STRYKER COMMUNICATIONS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Stryker Visum™ LED Surgical Lighting System is to illuminate the operative site during surgical procedures with high intensity light.
    Device Description
    The Stryker Visum™ LED Surgical Lighting System is intended to illuminate the operative site during surgical procedures. Light functions can be controlled from within the sterile field, from a wall mounted control panel, or through the Stryker SIDNE™ device (K022393). The Stryker Visum™ LED Surgical Lighting System will be used in indications the same as other surgical lights currently offered for commercial distribution in the United States. The Stryker Visum™ LED Surgical Lighting System is suitable for all major and minor surgical procedures throughout the hospital. The light moves via an easy to move pivoting suspension and has a completely sealed lighthead for safety and hygiene. Intensity is variable from 50,000 Lux to 160,000 Lux and each lighthead has redundant light sources that are not affected by individual source failure. The light quality is based upon a multiple reflector design combined with a heat removing conductive path to provide shadow free, cool light. All systems are ceiling, wall, or mobile mounted lights and each provides sufficient illumination for all types of surgical procedures. The ceiling mounted lights are available in single, dual, and triple configurations and may also be combined with a separate arm to hold a viewing monitor.
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    K Number
    K033132
    Device Name
    STRYKER SWITCHPOINT INFINITY
    Manufacturer
    STRYKER COMMUNICATIONS CORP.
    Date Cleared
    2004-09-02

    (338 days)

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

    STRYKER COMMUNICATIONS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Switchpoint Infinity™ Control System is a medical device that is designed to allow direct control of the state, selection, and settings of room equipment, and audio/video equipment and indirect control through the Stryker Endoscopy Sidne™ System of the state, selection, and settings of surgical equipment in the operating room. The Switchpoint Infinity™ Control System is also an integrated voice, video, and data router and teleconferencing interface for the operating room. The intent of the Switchpoint Infinity™ Control System is to allow operating room personnel a center point for controlling all equipment and communication in surgery. The Stryker Switchpoint Infinity™ Control System is indicated for use with the Stryker Endoscopy Sidne™ System [510(k) # K022393] and Sidne™ compatible endoscopic and general surgery devices. The users of Switchpoint Infinity™ Control System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, urologists, and any other surgeon whom requires the use of voice, video, or control in the operating room or a teleconferencing interface.
    Device Description
    The Switchpoint Infinity™ Control System is a medical device that is designed to allow direct control of the state, selection, and settings of room equipment, and audio/video equipment and indirect control through the Stryker Endoscopy Sidne™ System of the state, selection, and settings of surgical equipment in the operating room. The Switchpoint Infinity™ Control System is also an integrated voice, video, and data router and teleconferencing interface for the operating room.
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