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510(k) Data Aggregation

    K Number
    K041560
    Device Name
    FLO-ASSISTANT
    Date Cleared
    2004-09-28

    (110 days)

    Product Code
    Regulation Number
    884.1730
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FLO-ASSISTANT

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

    The Nortech Flo-Assistant™ Product is indicated to provide a squeezing mechanism to a tubing set, providing increased capacity fluid irrigation for arthroscopic procedures.

    Device Description

    The Flo-Assistant™ is designed to be used with the Nortech® 7-510-33 Flo-Assistant™ tubing set for increased fluid capacity. The device is comprised of a main unit, cable and foot pedal assembly.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information regarding acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) summary for the Flo-Assistant™ device, primarily focusing on its description, intended use, and assertion of substantial equivalence to predicate devices. It does not include details about clinical trials, performance specifications, or study methodologies.

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    K Number
    K001325
    Date Cleared
    2000-08-18

    (114 days)

    Product Code
    Regulation Number
    876.5130
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FLO ASSISTANT, MODEL 4-250-00

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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