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510(k) Data Aggregation

    K Number
    K032981
    Device Name
    SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09
    Date Cleared
    2004-04-22

    (211 days)

    Product Code
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    INVAMED TECHNOLOGIES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SPpro™ ESP is an anesthesia conduction needle incorporating a needle tip shielding mechanism to aid in the prevention of needle-stick injuries after use to deliver an anesthetic and/or therapeutic agent to provide regional anesthesia. The needle can be used for a single dose administration or in conjunction with a catheter for continuous regional anesthesia.
    Device Description
    The SPpro™ ESP anesthesia conduction needle is a single use device for injection of local anesthetics into body cavities other than blood vessels. The device will be packaged as sterile single units or incorporated into kits. The device is designed with a tip shield and sheath mechanism integrated with the introducer hub to aid in the prevention of sharps injuries. After activation the shield covers the introducer tip. The device is disposed of according to institutional procedure in a sharps container.
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