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510(k) Data Aggregation

    K Number
    K042285
    Device Name
    UNICRYL M
    Manufacturer
    UNITED MEDICAL INDUSTRIES CO. LTD.
    Date Cleared
    2004-12-10

    (108 days)

    Product Code
    NEW
    Regulation Number
    878.4840
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    UNICRYL M

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

    UniCryl M is indicated for use in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery but not for use in cardiovascular, neurological procedures, or microsurgery.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device called "UniCryl M," which is an absorbable polydioxanone surgical suture. It is a regulatory document and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other technical details requested in your prompt.

    Therefore, I cannot extract the requested information from this document. The document primarily focuses on the regulatory approval process and the determination of substantial equivalence to a predicate device.

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