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510(k) Data Aggregation

    K Number
    K993046
    Device Name
    FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000
    Manufacturer
    FIBRA SONICS, INC.
    Date Cleared
    1999-11-22

    (73 days)

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

    FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000

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

    The Fibra Sonics LithoSonic Model LS-2000 Ultrasonic Lithotripsy System is intended to fragment urinary calculi in the kidney, ureter, and bladder.

    Device Description

    Not Found

    AI/ML Overview

    This document is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain information about acceptance criteria, device performance, study details (sample size, provenance, expert qualifications, adjudication), MRMC studies, standalone performance, or training set details. It is a regulatory approval document, not a study report.

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