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510(k) Data Aggregation

    K Number
    K042284
    Device Name
    UNIMIDE
    Manufacturer
    UNITED MEDICAL INDUSTRIES CO. LTD.
    Date Cleared
    2004-12-03

    (101 days)

    Product Code
    GAR
    Regulation Number
    878.5020
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    UNIMIDE

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

    UniMide is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for a medical device called UniMide, which is a nonabsorbable polyamide surgical suture.

    This document does not include information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The letter primarily focuses on the FDA's determination of substantial equivalence to a predicate device, allowing the manufacturer to market UniMide.

    Therefore, I cannot fulfill your request for details on acceptance criteria and study information.

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