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510(k) Data Aggregation

    K Number
    K042486
    Device Name
    PROCEDUR 10 SYRINGE DEVICE
    Manufacturer
    AVANCA MEDICAL DEVICES, INC.
    Date Cleared
    2005-01-21

    (130 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K980987
    Why did this record match?
    Device Name :

    PROCEDUR 10 SYRINGE DEVICE

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

    The Procedur-10 device is used to inject fluids into, or withdraw fluids from, the body.

    Device Description

    The Procedur-10 device is a piston syringe

    AI/ML Overview

    I am sorry, but the provided text only contains a 510(k) summary and FDA clearance letter for a piston syringe called "Procedur-10." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement that would be required to answer your request.

    The K042486 submission is for a Class II medical device (Piston Syringe) and focuses on demonstrating substantial equivalence to a predicate device (Becton Dickinson Single-Use Hypodermic Syringes K980987). Substantial equivalence typically relies on comparing technological characteristics and intended use, rather than extensive clinical performance studies with acceptance criteria as you've requested for AI/software devices.

    Therefore, I cannot extract the information required to fill out the table and answer your questions regarding acceptance criteria, study details, and AI-related aspects.

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