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510(k) Data Aggregation

    K Number
    K103239
    Device Name
    IRRIGATION SYSTEM
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Date Cleared
    2010-12-30

    (58 days)

    Product Code
    OCX
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    K112318,K210342
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Irrigation System (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.

    Device Description

    Irrigation System (tubing and accessories to accommodate various endoscopes and irrigation pumps)

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for an "Irrigation System." It is a regulatory approval document and does not contain any information regarding acceptance criteria or a study proving that a device meets such criteria.

    Therefore, I cannot extract the requested information from this document.

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    K Number
    K961192
    Device Name
    IRRIGATION SYSTEM
    Manufacturer
    LINVATEC CORP.
    Date Cleared
    1996-04-26

    (31 days)

    Product Code
    ERL
    Regulation Number
    874.4250
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    K981637
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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