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510(k) Data Aggregation

    K Number
    K042286
    Device Name
    UNIESTER C
    Manufacturer
    UNITED MEDICAL INDUSTRIES CO. LTD.
    Date Cleared
    2004-12-01

    (99 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    UNIESTER C

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

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

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text is a letter from the FDA regarding the 510(k) clearance of the UniEster C surgical suture. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods. Therefore, I cannot generate the requested table and study details based on this input.

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