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510(k) Data Aggregation

    K Number
    K160198
    Device Name
    UreTron MultiProbe Lithotripter System
    Manufacturer
    Med-Sonics Corp
    Date Cleared
    2016-02-23

    (26 days)

    Product Code
    FFK
    Regulation Number
    876.4480
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    UreTron MultiProbe Lithotripter System

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

    The UreTron Multi Probe Lithotripter System is intended for the fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for the UreTron MultiProbe Lithotripter System. It acknowledges the device's substantial equivalence to existing devices and outlines regulatory compliance requirements.

    This document does not contain any information regarding:

    • Acceptance criteria for device performance.
    • Details of a study that proves the device meets acceptance criteria.
    • Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
    • Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
    • Type of ground truth used or details about a training set.

    Therefore, I cannot fulfill your request based on the provided input.

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