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510(k) Data Aggregation

    K Number
    K962346
    Device Name
    PAPILLOTOME
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Date Cleared
    1996-08-08

    (51 days)

    Product Code
    KNS
    Regulation Number
    876.4300
    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 Papillotome is intended for use in endoscopic papillotomy and sphincterotomy.

    Device Description

    The Papillotome is intended for use in endoscopic papillotomy and sphincterotomy.

    AI/ML Overview

    This document is a 510(k) summary for a medical device called "Papillotome." It describes the intended use, contraindications, potential complications, and manufacturing overview of the device. However, it does not contain any information regarding acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML powered device.

    Therefore, I cannot provide the requested information based on the provided text. The document is solely focused on the regulatory submission for a physical medical device and lacks any data or details pertaining to an AI/ML study.

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