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510(k) Data Aggregation

    K Number
    K231603
    Device Name
    Standard Staple-Line Reinforcement (SSLR23)
    Manufacturer
    Standard Bariatrics, Inc.
    Date Cleared
    2023-10-06

    (127 days)

    Product Code
    OXC
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Standard Bariatrics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Standard Staple-Line Reinforcement is indicated for use in bariatric procedures in which gastric tissue transection and resection with staple line reinforcement is needed.
    Device Description
    The Standard Staple-Line Reinforcement (SSLR23) is an implantable device designed to be used with Standard Bariatrics' TITAN SGS23R device (K210278) during laparoscopic surgery to position, clamp, staple, and resect long planes of soft flat tissue and organs, such as the stomach. The SSLR23 device consists of 2 (two) sheets of GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material, configured to be used only with TITAN SGS23R and which provides a continuous sheet of Staple-Line Reinforcement for the entire length of the staple-line, up to 23cm in length. The device contains an applicator to aid in the installation of the SSLR23 on the TITAN SGS23R jaws. The SSLR23 device is single-use and supplied sterile.
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    K Number
    K222085
    Device Name
    Standard Tapered Bougie, 38 Fr.
    Manufacturer
    Standard Bariatrics, Inc.
    Date Cleared
    2022-10-31

    (108 days)

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

    Standard Bariatrics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Standard Tapered Bougie, 38Fr (STB38) is indicated for use in conjunction with the Titan SGS® Stapler in vertical sleeve gastrectomy pouch creation for the application, stomach decompression, drainage of gastric fluids, irrigation and insufflation, and to serve as a sizing guide.
    Device Description
    The Standard Tapered Bougie, 38Fr (STB38) is a non-sterile, single patient use device. The device comprises a tube with a rounded tip featuring drainage holes, and a tapered balloon at the distal end. The proximal end of the Standard Tapered Bougie, 38Fr (STB38) includes a standard Luer lock valve for balloon inflation/deflation using the 60mL/CC syringe (provided) and a 7.5mm inner diameter straight tube for connection to operating room suction, Standard Bougie Hand Pump (SBHP) or tapered tip syringe.
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