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510(k) Data Aggregation

    K Number
    K020500
    Device Name
    UNIVEC BIFURCATED SLIDING SHEATH SYRINGE
    Manufacturer
    UNIVEC, INC.
    Date Cleared
    2002-03-19

    (33 days)

    Product Code
    SCL,LDH
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    UNIVEC BIFURCATED SLIDING SHEATH SYRINGE

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

    The Univec Bifurcated Sliding Sheath Syringe is a safety version of a bifurcated needle attached to a syringe barrel with the Univec Sliding Sheath Syringe mechanism. The Univec Sliding Sheath mechanism is used to aid in the prevention of needle stick injuries. This device is used in the same manner as a standard Bifurcated Needle to deliver vaccine or allergen to the patient.

    Device Description

    The Univec Bifurcated Sliding Sheath Syringe is a safety version of a bifurcated needle attached to a syringe barrel with the Univec Sliding Sheath Syringe mechanism.

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot answer your request. The document is an FDA 510(k) clearance letter for a medical device (Univec Bifurcated Sliding Sheath Syringe), which confirms its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria for device performance, specific studies proving performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.

    The document primarily focuses on regulatory classification and general compliance with FDA regulations, not detailed performance validation data.

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