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510(k) Data Aggregation

    K Number
    K990863
    Date Cleared
    1999-04-06

    (21 days)

    Product Code
    Regulation Number
    876.5980
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Flexiflo PolyG Gastrostomy Tube is intended for gastric placement through a mature gastrocutaneous fistula, or one created during a Stamm or Witzel procedure. The tube functions as a conduit to facilitate enteral feeding, and may be used in pediatric, adult or elderly patients who cannot consume an adequate diet orally. Enteral feeding may be indicated for patients with a functioning gut who require short- to long-term feeding support, such as post-trauma patients, post-surgical patients, burn patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom malnutrition exists, or may result, secondary to an underlying disease or condition. The tube may also be used for gastric decompression or evacuation of gastric contents.

    Device Description

    Modification to FlexiFlo PolyG® Gastrostomy Tube

    AI/ML Overview

    The provided text is a Food and Drug Administration (FDA) letter regarding a 510(k) premarket notification for a medical device. This type of document is a regulatory approval letter and does not contain information about acceptance criteria or a study proving that a device meets those criteria.

    Therefore, I cannot provide the requested information based on the input text. The document states that the FDA has determined the device to be "substantially equivalent" to legally marketed predicate devices, which is a regulatory classification, not a performance validation based on specific acceptance criteria and a study.

    To answer your request, I would need a document detailing the device's technical specifications, performance goals, and results from a clinical or non-clinical study.

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