Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K230488
    Device Name
    EL27-Compact; Sterile EHL-Probes
    Manufacturer
    Walz Elektronik GmbH
    Date Cleared
    2023-08-31

    (189 days)

    Product Code
    FFK, REV
    Regulation Number
    876.4480
    Why did this record match?
    Applicant Name (Manufacturer) :

    Walz Elektronik GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EL27-Compact is a device to be used together with EHL-probes from Walz Elektronik GmbH for disintegration of concernments in the upper and lower urinary tract and in gastroenterology, particularly in the bile duct.
    Device Description
    The EL27-Compact is a device, designed to be used with Walz Elektronik GmbH disposable EHL-Probes for the fragmentation of concrements in the gastroenterology and urology. A physician inserts and pushes the disposable EHL probe through the working channel of an endoscope and places the tip of the probe in front of the stone surrounded with saline solution. With pressing the footswitch, the device provides electric pulse energy in form of a high-voltage pulse. This pulse generates high pressure shockwaves that fragment hard stones. The EL27-Compact is a table-top device and consists of the generator itself, the power cord, the footswitch, a probe cable for connection between the device and the EHL-probes.
    Ask a Question

    Page 1 of 1