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510(k) Data Aggregation

    K Number
    K980808
    Device Name
    ENDO FMS UROLOGY
    Manufacturer
    FUTURE MEDICAL SYSTEMS, INC.
    Date Cleared
    1998-05-08

    (66 days)

    Product Code
    LJH
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ENDO FMS UROLOGY

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

    The ENDO FMS® UROLOGY is a fluid management system used to maintain adequate irrigation pressure and flow in endoscopic Urology procedures, including all endoscopic procedures in the Kidney, Ureter/Urethra , Bladder and Prostate.

    Device Description

    ENDO FMS® UROLOGY is a fluid management system.

    AI/ML Overview

    This is a premarket notification (510(k)) letter from the FDA regarding the ENDO FMS® UROLOGY (Fluid Management System). This document is an approval letter and does not contain detailed information about acceptance criteria or study results. A 510(k) submission typically demonstrates substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies like those required for Pre-Market Approval (PMA).

    Therefore, based solely on the provided text, I cannot provide the requested information. The document primarily focuses on the FDA's decision regarding the substantial equivalence of the device.

    To address your request, I would need to review the actual 510(k) submission (K980808) which would detail the technical specifications, performance testing, and comparison to the predicate device.

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