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510(k) Data Aggregation

    K Number
    K993424
    Device Name
    THE TRUE Y CLIP, THE MICRO Y CLIP, THE LAPAROSCOPIC Y CLIP
    Manufacturer
    Y-CLIP ASSOCIATES
    Date Cleared
    1999-12-23

    (72 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended to be used for laproscopic and open surgical procedures to Ligate tissue and Blood vessels and Lymphatics

    Device Description

    Not Found

    AI/ML Overview

    This letter is a 510(k) clearance from the FDA, indicating that the device has been found substantially equivalent to a predicate device. It does not contain information about the device's acceptance criteria, performance studies, or details regarding the establishment of ground truth as typically found in a clinical study report or a more detailed regulatory submission.

    Therefore, I cannot provide the requested information based on the given document. The document primarily focuses on regulatory clearance rather than scientific validation details.

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