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510(k) Data Aggregation

    K Number
    K965136
    Device Name
    UROSURGE UROTHERM FLUID WARMING SYSTEM
    Manufacturer
    PRINCETON REGULATORY ASSOC.
    Date Cleared
    1998-10-16

    (662 days)

    Product Code
    LHC
    Regulation Number
    890.5950
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    UROSURGE UROTHERM FLUID WARMING SYSTEM

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

    The UroSurge UroTherm™ Fluid Warming System is intended to varm sterile irrigating solutions to normothermic temperatures (37°C) for use in medical/surgical procedures. Not for use with blood or blood products.

    Device Description

    UroSurge UroTherm™ Fluid Warning System

    AI/ML Overview

    The provided text is a 510(k) Pre-market Notification letter from the FDA, which primarily confirms that the UroSurge UroTherm Fluid Warming System is substantially equivalent to a legally marketed predicate device. This document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as this information is not present in the provided text.

    The document focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study report.

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