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510(k) Data Aggregation

    K Number
    K020544
    Device Name
    WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS, INC.
    Date Cleared
    2002-03-12

    (25 days)

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

    WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE

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

    The Churchill Medical Systems Wing Safe Huber Type Needle Sets intended use is for the delivery of medical fluids into implantable chemotherapy ports.

    Device Description

    Churchill Medical Systems Wing Safe Huber Needle Set

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Churchill Medical Systems, Inc., regarding a medical device called "Wing Safe Huber Type Needle Sets." This document primarily grants clearance for the device to be marketed based on its substantial equivalence to a legally marketed predicate device.

    It does not contain any information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement. These details are typically found in the actual 510(k) submission, which is a much more extensive document. The provided letter is merely the FDA's decision letter following their review of such a submission.

    Therefore, I cannot fulfill your request for information on acceptance criteria and study details based on the provided text.

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