LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K033166
    Device Name
    KACEY INSULIN SYRINGE
    Manufacturer
    KACEY, INC.
    Date Cleared
    2003-12-12

    (73 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This product is intended for use by individuals who have been directed by and are under the supervision of professional staff to use insulin injections as a means to control the effects of diabetes.

    The product is intended to be used in any setting that meets the needs of the user.

    Device Description

    Piston Syringe

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a Kacey Insulin Syringe. This document does not contain information about the acceptance criteria and the study that proves the device meets those criteria. It is a regulatory approval letter, not a scientific study report.

    Therefore, I cannot provide a response to your request based on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1