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510(k) Data Aggregation

    K Number
    K980617
    Device Name
    MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER
    Manufacturer
    UROHEALTH SYSTEMS, INC.
    Date Cleared
    1998-04-09

    (76 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    UROHEALTH SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in a variety of open procedures, such as abdominal, pediatric, thoracic, gynecologic, etc. and for use in endoscopic and laparoscopic the assol gynocelling hemostatic transection of vessels and other tissue structures.
    Device Description
    Richard-Allan's Reflex AEC 35, with shorter shaft length is substantially equivalent to our currently marketed Reflex AEC 35. These instruments have the same component materials, method of manufacturing, and method of sterilization. These instruments have similar instructions for use.
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    K Number
    K970107
    Device Name
    INTUBATION ENDOSCOPE AND INTRODUCER SHEATH
    Manufacturer
    UROHEALTH SYSTEMS, INC.
    Date Cleared
    1997-11-18

    (309 days)

    Product Code
    EOQ
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    UROHEALTH SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intubation Endoscope and Introducer Sheath are used in the direct visualization in the trachea and lungs during fiberoptically assisted intubation and airway management.
    Device Description
    UROHEALTH Intubation Endoscope Introducer Sheath is a device that consists a malleable or nonmalleable introducer sheath that houses a channel for insufflation of oxygen or fluid delivery, a deflecting mechanism for the distal tip, a channel for scope insertion, and a distal window. The reusable fiber optic imaging and illumination system consists of a focusing ocular lens, a distal objective lens, and a connection for a fiber optic light cable.
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    K Number
    K972510
    Device Name
    PIVOTAL SCISSOR
    Manufacturer
    UROHEALTH SYSTEMS, INC.
    Date Cleared
    1997-11-13

    (133 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    UROHEALTH SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pivotal devices are sterile, disposable, general surgical instruments for use in endoscopic or open surgical procedures to dissect, transect, manipulate, coagulate, and/or grasp tissue.
    Device Description
    The Pivotal instrument and similar currently marketed devices are intended to cut, grasp, manipulate, and coagulate tissue during surgical procedures. The similar marketed endoscopic devices are designed to be used with monopolar electrosurgery and are disposable devices supplied sterile to the user. These devices are available in a variety of blade and jaw configurations. These devices have similar thermoplastic ringed handles that open and close the jaws. The grasper devices are all equipped with a ratchet mechanism that allows the tissue to be held in the jaws without the need for applying constant pressure on the ringed handles.
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