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510(k) Data Aggregation

    K Number
    K992040
    Device Name
    FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES
    Manufacturer
    FIBER IMAGING TECHNOLOGIES, INC.
    Date Cleared
    1999-08-06

    (50 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Schoelly Flexilux II Arthroscopes are indicated to permit a physician or surgeon to view the operative site during an arthroscopic procedure on the knee, shoulder, jaw, wrist, ankle, and elbow.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Scholly Flexilix II Arthroscopic and Accessories". It does not contain information about the acceptance criteria, specific studies, or performance data for the device.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results.

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