LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K973525
    Device Name
    MAURICE WORLDWIDE SHUNT SYSTEM
    Manufacturer
    INTEGRA NEUROCARE LLC.
    Date Cleared
    1997-12-16

    (90 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MAURICE WORLDWIDE SHUNT SYSTEM

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

    The Maurice Worldwide Shunt System is utilized in the treatment of hydrocephalic patients. It is a component in systems designed to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneal cavity.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the "Maurice Worldwide Shunt System." It states that the device is substantially equivalent to a predicate device and can be marketed. However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    The letter is a regulatory approval document and does not describe the specific tests or data used to support the substantial equivalence claim. Therefore, I cannot extract the requested information from the provided input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1