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510(k) Data Aggregation

    K Number
    K042427
    Device Name
    GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
    Manufacturer
    GENEMED, INC.
    Date Cleared
    2004-12-03

    (86 days)

    Product Code
    LNS
    Regulation Number
    876.5990
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENEMED, INC.

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

    The Genestone Exel (XL) Extracorporeal Shock Wave Lithotripter is indicated for use in the non-invasive disintegration of kidney (renal pelvis and renal calyceal) and upper ureteral stones between 5 and 20 mm in size.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the Genestone Exel (XL) Extracorporeal Shockwave Lithotripter. It acknowledges that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria or a study proving the device meets those criteria.

    A 510(k) clearance evaluates substantial equivalence to a predicate device, not necessarily new performance data against specific acceptance criteria. To find the information you requested, one would typically need to review the original 510(k) submission document itself, which is not provided here.

    Therefore, I cannot provide the requested information based on the provided text.

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