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510(k) Data Aggregation

    K Number
    K020629
    Device Name
    SIMPLICITY SIMPLEX SOFT INFUSION SET
    Manufacturer
    STERLING MEDIVATIONS, INC.
    Date Cleared
    2002-04-01

    (34 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SIMPLICITY SIMPLEX SOFT INFUSION SET

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

    The intended use of the Simplicity Simplex Soft Infusion Set is to provide a means for infusion and/or injection of fluids into the body below the surface of the skin when attached to an external pump or syringe.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called "Simplicity™ Simplex Soft Infusion Set." This document does not contain information about acceptance criteria or a study proving the device meets them. Instead, it informs the manufacturer that their device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

    The letter discusses regulatory classifications, general controls, and compliance requirements, but it does not include details on performance metrics, study designs, sample sizes, or ground truth establishment relevant to the request.

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