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510(k) Data Aggregation

    K Number
    K051142
    Device Name
    ANGIODYNAMICS TUMESCENT INFUSION DEVICE
    Manufacturer
    ANGIODYNAMICS, INC.
    Date Cleared
    2005-07-13

    (70 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AngioDynamics, Inc. Tumescent Infusion Device is indicated for the introduction of dilute lidocaine solutions into subcutaneous tissues for the purpose of tumescent local anesthesia.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the AngioDynamics, Inc. Tumescent Infusion Device. It states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices.

    This document DOES NOT contain the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment relevant to AI/algorithm performance.

    The letter is a regulatory approval document and does not include performance data or studies typically required for AI/ML device submissions. Therefore, I cannot provide a response to your numbered requests based on the content of this document.

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