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510(k) Data Aggregation

    K Number
    K983647
    Device Name
    ECHO-COAT ULTRASOUND NEEDLES
    Manufacturer
    STS BIOPOLYMERS
    Date Cleared
    1999-01-20

    (96 days)

    Product Code
    MJG
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    STS BIOPOLYMERS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ECHO-COAT™ Ultrasound Needle is indicated for use where improved visibility on ultrasound images is required compared to an uncoated needle. The coated needle also assumes the specific indications for use of the currently marketed uncoated needle, for example biopsy, amniocentesis, vascular access, aspiration, and drainage needles.
    Device Description
    STS Biopolymers, Inc. will purchase in bulk currently marketed needles designated by application (biopsy, aspiration, amniocentesis, etc.), needle type (spinal, Chiba, Franseen, other), needle gauge (11 to 30), and length (3 to 20 cm), and then apply a polymer coating. The coating, called ECHO-COAT™, is visible in ultrasound images, assisting with positioning. The coated needles will be repackaged as single-use devices, sterilized with EtO, and distributed commercially under the STS Biopolymers, Inc. name.
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