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510(k) Data Aggregation

    K Number
    K960177
    Device Name
    P.E.G. PATIENT CARE KIT
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Date Cleared
    1996-03-29

    (73 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Percutaneous endoscopic gastrostomy (PEG) has become the method of choice for patients, both adults and children, unable to take nutrition through normal means, yet, have a functional gastrointestinal tract. Percutaneous endoscopic gastrostomy is a less invasive and less traumatic method of placement than a surgical procedure.
    A U.S.E. PATIENT CARE KIT includes all necessary products for maintenance of the Pull or Guidewire P.E.G. (eg. feeding adapter, and accessory products - manual, cleaning brush, antibiotic ointment, etc...)

    Device Description

    A U.S.E. PATIENT CARE KIT includes all necessary products for maintenance of the Pull or Guidewire P.E.G. (eg. feeding adapter, and accessory products - manual, cleaning brush, antibiotic ointment, etc...)

    AI/ML Overview

    The provided text describes a "P.E.G. Patient Care Kit" and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

    The document is a "Summary of Safety and Effectiveness" which briefly outlines the product, its overview, contraindications, and manufacturing processes based on existing standards and predicate devices. It lists bibliographic references for the medical procedure itself, not for a specific study validating the performance of this particular kit against defined acceptance criteria.

    Therefore, I cannot populate the requested information because the input text does not contain it.

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