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510(k) Data Aggregation

    K Number
    K042282
    Device Name
    UNISILK
    Manufacturer
    UNITED MEDICAL INDUSTRIES CO. LTD.
    Date Cleared
    2004-12-01

    (99 days)

    Product Code
    GAP
    Regulation Number
    878.5030
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    UNISILK

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

    UniSilk 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 510(k) premarket notification letter from the FDA regarding the UniSilk surgical suture. It establishes substantial equivalence but does not contain any information about acceptance criteria, device performance metrics, study design, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device evaluation.

    Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and the study that proves the device meets them, as none of that information is present in the provided document. The document pertains to a traditional medical device (suture) and its regulatory clearance, not an AI/ML diagnostic or prognostic tool.

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