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510(k) Data Aggregation

    K Number
    K182248
    Device Name
    Aspire Venting Tube
    Manufacturer
    Aspire Bariatrics, Inc
    Date Cleared
    2018-11-13

    (85 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aspire Bariatrics, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aspire Venting Tube is intended for use in adult patients who require gastric decompression.
    Device Description
    The Aspire Venting Tube is a gastrostomy tube used to provide secured access to the stomach through the initial placement or a formed stoma. The tube is designed to facilitate decompression.
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    K Number
    K180725
    Device Name
    Aspire Introducer Needle
    Manufacturer
    Aspire Bariatrics, Inc.
    Date Cleared
    2018-07-11

    (113 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aspire Bariatrics, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aspire Introducer Needle is intended to be used for guidewire introduction during percutaneous gastrointestinal procedures.
    Device Description
    The Aspire Introducer Needle is a single use, sterile, non-pyrogenic, disposable product used to provide initial percutaneous access. It is comprised of a stainless steel needle with a plastic sheath to be used in guidewire placement during percutaneous endoscopic procedures. The needle is used once the stomach is insufflated and the site verified through trans-illumination and visualization of finger indentation through the endoscope. The introducer needle is similar in design to other needles currently on the market for the same intended purpose. The dimensions of this device fall within the range of currently marketed introducer needles with the same intended use, and the materials are similar in that the needle is made from stainless steel and the other components are plastics. The device also incorporates a female luer lock hub in the design, also provided in the predicate devices.
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