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510(k) Data Aggregation

    K Number
    K022057
    Date Cleared
    2002-11-22

    (151 days)

    Product Code
    Regulation Number
    880.5570
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Hypodermic single lumen needle: To inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Piston Syringe: To inject fluids into, or withdraw fluids from the body.

    Device Description

    Not Found

    AI/ML Overview

    This is an FDA 510(k) clearance letter for the "KG Medix Disposable Syringe 1, 3, 5, 10, 20, 30, 50, ML's" and "KG Medix Device Name : SafeOne Disposable Syringe & Needle."

    Based on the provided text, there is no information regarding acceptance criteria or a study that proves the device meets those criteria, as this document is a regulatory clearance letter, not a performance study report. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, but it does not detail specific performance metrics or clinical study results.

    Therefore, I cannot provide the requested information.

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