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510(k) Data Aggregation

    K Number
    K962330
    Device Name
    AMO ARTHOSCOPES
    Manufacturer
    AMERICAN MICROPTIKS, INC.
    Date Cleared
    1996-09-11

    (86 days)

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

    AMERICAN MICROPTIKS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Like other legally marketed arthroscopes, the AMO Arthroscope is indicated for use in minimally invasive procedures of the knee, shoulder and ankle joints, for joint examination, biopsy, arthroscopy, diagnosis of ioint disease. The device provides a clear view of the joint structures such as femoral condyles, medial meniscus, cruciate ligament, and other anatomical structures.
    Device Description
    The AMO Arthroscope is a device that will be provided non-sterile for arthroscopic procedures. The device has a basic design similar to those already sold legally in the U.S.A. Its construction consists of an eyepiece, body, light guide and a shaft. The shaft contains an outer tube, an inner tube, with light-carrying fibers sandwiched between these tubes. The inner tube contains the optical system.
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