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510(k) Data Aggregation

    K Number
    K993970
    Device Name
    MICRINS MICROSURGICAL SUTURE
    Manufacturer
    MICRINS SURGICAL, INC.
    Date Cleared
    2000-03-30

    (128 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 :

    MICRINS MICROSURGICAL SUTURE

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

    Micrins microsurgical suture 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

    I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for a "Microsurgical Suture" device, indicating that the device is substantially equivalent to previously reclassified devices. It outlines indications for use, limitations on manufacturing materials, and regulatory requirements, but it does not detail specific performance studies or acceptance criteria for device performance.

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