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510(k) Data Aggregation

    K Number
    K990175
    Device Name
    SHEATHES (NON-LATEX), STERILE
    Manufacturer
    SHEATHING TECHNOLOGIES, INC.
    Date Cleared
    1999-04-21

    (92 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SHEATHES (NON-LATEX), STERILE

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

    STERILE NON-LATEX PROBE COVERS ARE INDICATET) DURING DIAGNOSTIC ULTRASOUND PROCEDURES in CASES WHERE.. PATIENT SENSITIVITY TO LATEX is SPECULATIVE.

    Device Description

    Sheathes (Non-Latex), Sterile

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a non-latex sterile sheath, not a study report or clinical trial. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, or performance data for a device.

    The clearance letter simply states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It does not provide any specific quantitative acceptance criteria or the results of any performance studies.

    To answer your questions, I would need a different document, such as a summary of safety and effectiveness data (SSE) or a clinical study report that was part of the 510(k) submission.

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