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510(k) Data Aggregation

    K Number
    K973120
    Device Name
    READYCATH CATHETER
    Manufacturer
    MEDICAL TECHNOLOGIES OF GEORGIA
    Date Cleared
    1998-02-25

    (189 days)

    Product Code
    GBM
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    READYCATH CATHETER

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

    The MMG InstantCath Pre-lubricated Catheter is intended to be used as a urinary incontinence device designed to drain urine from the bladder.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the INSTANTCATH (Readycath) Catheter. It does not contain information about the acceptance criteria and study detailed in the request. The letter only confirms that the device is substantially equivalent to a predicate device and can be marketed.

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

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