LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K994059
    Device Name
    CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07
    Manufacturer
    HDC CORP.
    Date Cleared
    2000-10-13

    (319 days)

    Product Code
    CAZ
    Regulation Number
    868.5140
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07

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

    The CLA Kit (Nerve Block Infusion Kit) is intended for the injection of local anesthetic to achieve peripheral nerve conduction blocks, by use of an insulated hollow needle for electrical stimulation to locate peripheral nerves, and the injection of local anesthetic either directly through the needle, or for up to 72 hours via a catheter inserted through the needle.

    Device Description

    CLA Kit (Nerve Block Infusion Kit)

    AI/ML Overview

    This document is a 510(k) clearance letter for the "CLA Kit (Nerve Block Infusion Kit)". It does not contain information about acceptance criteria or a study proving that a device meets such criteria. It primarily focuses on the FDA's determination of substantial equivalence to legally marketed predicate devices and outlines regulatory responsibilities.

    Therefore, I cannot provide the requested information based on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1