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510(k) Data Aggregation

    K Number
    K012044
    Device Name
    BI-PHASIC INFILTRATOR
    Manufacturer
    RELIANCE MEDICAL CORP.
    Date Cleared
    2001-08-28

    (60 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BI-PHASIC INFILTRATOR

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

    The Reliance Medical Bi-Phasic Infiltrator indication for use is: General surgical fluid irrigation and infiltration.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study design, sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) clearance letter from the FDA for a device called "Bi-Phasic Infiltrator," indicating it is substantially equivalent to a legally marketed predicate device for general surgical fluid irrigation and infiltration. It does not contain the detailed study information you are requesting.

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