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510(k) Data Aggregation

    K Number
    K971615
    Device Name
    PATTISON ESOPHAGEAL DILATOR
    Manufacturer
    TRI-MED SPECIALTIES, INC.
    Date Cleared
    1997-07-24

    (83 days)

    Product Code
    KNQ
    Regulation Number
    876.5365
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TRI-MED SPECIALTIES, INC. Pattison Esophageal Dilator is for dilation of, but not limited to, peptic esophageal strictures, caustic strictures, upper esophageal webs, lower esophageal (Schatzki) rings, and palliation of esophageal cancer or lymphoma.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Pattison Esophageal Dilator." The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

    Crucially, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

    510(k) clearances are based on demonstrating substantial equivalence to a predicate device, not necessarily on new clinical performance data or studies that establish novel acceptance criteria. The focus is on comparing the new device's design, materials, indications for use, and performance characteristics to those of an already legally marketed device.

    Therefore, I cannot extract the requested information from the provided text because it is not present.

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