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510(k) Data Aggregation

    K Number
    K050499
    Device Name
    PROBLOC, HN SERIES AND PROLONG, PL SERIES
    Manufacturer
    LIFE-TECH, INC.
    Date Cleared
    2005-05-17

    (78 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Prolong is used to administer a patient conduction, regional, or local anesthesia. ProBloc is used in performance of regional anesthesia block.

    Device Description

    Not Found

    AI/ML Overview

    This document does not contain information about acceptance criteria, device performance, or a study proving that the device meets acceptance criteria. The document is a 510(k) substantial equivalence determination letter from the FDA for a device named "ProBloc" and "Prolong," which are anesthesia conduction needles. It states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices for the indications for use stated.

    Therefore, I cannot provide the requested information.

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