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    K Number
    K191594
    Device Name
    Nuvis Battery Arthroscope
    Manufacturer
    Integrated Endoscopy, Inc.
    Date Cleared
    2019-07-11

    (24 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Integrated Endoscopy, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Integrated Endoscopy's Nuvis® Battery Arthroscope is an endoscopic device introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy . Integrated Endoscopy's Nuvis® Battery Arthroscopes are indicated for use in arthroscopic procedures performed in the knee, shoulder, hip, wrist (carpel tunnel syndrome), temporal mandibular joint, ankle, elbow, and feet (plantar fascia release).
    Device Description
    Integrated Endoscopy's Battery Arthroscope is an optical instrument designed for illumination and visualization of internal anatomy of a patient within the knee, shoulder, and hip joint. Integrated Endoscopy's Battery Arthroscope has a 141mm working length, an outside diameter of 4mm, a field of view of 105 °, and a direction of 30 °. The Arthroscope is Battery Powered and three selectable light settings. The Arthroscope is designed to be used with a cannula compatible with a 4mm x 30° arthroscope with a working length of 141mm. The Arthroscope is supplied sterile and is for SINGLE USE ONLY. DO NOT REUSE OR RE-STERILIZE.
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    K Number
    K140903
    Device Name
    NUVIS ARTHROSCOPE
    Manufacturer
    INTEGRATED ENDOSCOPY, INC.
    Date Cleared
    2014-07-17

    (99 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRATED ENDOSCOPY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Integrated Endoscopy`s nuvis™ Arthroscope is an endoscopic device introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. Integrated Endoscopy's nuvis™ Arthroscopes are indicated for use in arthroscopic procedures performed in the knee, shoulder, hip, wrist (carpel tunnel syndrome), temporal mandibular joint, ankle, elbow, and feet (plantar fascia release).
    Device Description
    Integrated Endoscopy's nuvis™ Arthroscope is a non-deflectable rigid endoscopic optical instrument designed for illumination and visualization of internal anatomy of a patient within the knee, shoulder, and hip joint. Integrated Endoscopy's nuvis™ Arthroscope has a 140mm working length, an outside diameter of 4mm, a field of view of 105°, and a direction of view of 30°. The Arthroscope is designed to be used with a cannula compatible with a 4mm x 30° arthroscope with a working length of 140mm. The Arthroscope is supplied sterile and is for Single Use Only. It is not intended to be re-used or re-sterilized. The nuvis™ Arthroscope is a long tube containing a series of lenses. At the distal end, a lens captures the image of the object and transfers it via a series of lenses along the long tube to the eye piece or Camera Monitor System at the proximal end of the arthroscope. The nuvis™ Arthroscope is made of materials that are commonly used in medical devices such as stainless steel, copper, glass, sapphire and plastics. The operating site is magnified by approx. two to five times its actual size depending on the distance between the tip of the endoscope and the object being visualized.
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