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510(k) Data Aggregation

    K Number
    K973184
    Device Name
    PROSTATE SEEDING NEEDLE
    Manufacturer
    PROMEX, INC.
    Date Cleared
    1997-11-21

    (88 days)

    Product Code
    IWJ
    Regulation Number
    892.5650
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K052435
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For the manual application of a radionuclide source into the body for radiation therapy.

    Device Description

    Prostate Seeding Needle

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA for a Prostate Seeding Needle. It's a regulatory approval document and does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

    Therefore, I cannot answer your request based on the provided text. The document primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must adhere to.

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