LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K061143
    Device Name
    ROBERTSITE STOPCOCK
    Manufacturer
    HALKEY-ROBERTS CORP.
    Date Cleared
    2006-05-10

    (15 days)

    Product Code
    FMG
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K955782,K002689,K040634
    Why did this record match?
    Device Name :

    ROBERTSITE STOPCOCK

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

    The Robertsite® stopcock provides a needleless access port and multi-directional flow during fluid administration to a patient's vascular system.

    Device Description

    The device is a single use 4-way stopcock with one Robertsite® needleless injection port. The major device materials are polycarbonate and silicone.

    AI/ML Overview

    This document is a 510(k) Summary for the Robertsite® 4-Way Stopcock, a medical device. It does not contain information about an AI/ML powered device, therefore, the requested information about acceptance criteria, study details, and AI model performance is not present. The document focuses on establishing substantial equivalence to predicate devices, not on the performance of a diagnostic or predictive algorithm.

    Therefore, I cannot provide the requested information.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1