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510(k) Data Aggregation

    K Number
    K022406
    Device Name
    EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET
    Manufacturer
    EXELINT INTL. CO.
    Date Cleared
    2002-09-30

    (69 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET

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

    This product is intended to be used to collect blood for various blood tests. The EXELINT SecureTouch Vaculet Safety Blood Collection Set aids in the prevention of accidental needle stick injuries.

    Device Description

    EXEL Secure Touch Safety Vaculet Blood Collection Set

    AI/ML Overview

    The provided text is a 510(k) Premarket Notification from the FDA for a blood collection set. It does not contain information about acceptance criteria or a study that proves a device meets those criteria, as typically seen for AI/ML devices or complex diagnostic tools.

    Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set size, or how training ground truth was established).

    This document is a regulatory approval letter based on substantial equivalence to a predicate device, not a performance study report.

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