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510(k) Data Aggregation

    K Number
    K991656
    Device Name
    AED ARTHROSCOPE
    Manufacturer
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
    Date Cleared
    1999-12-02

    (203 days)

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

    AED ARTHROSCOPE

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

    The AED line of rigid Arthroscopes is indicated to provide illumination and visualization in: Diagnostic and operative arthroscope procedures.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the AED Arthroscope. It does not contain information about acceptance criteria, study details, or performance data for the device. The letter primarily confirms that the device is substantially equivalent to a predicate device and can be marketed.

    Therefore, I cannot provide the requested information based on the provided text.

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