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510(k) Data Aggregation

    K Number
    K142656
    Device Name
    Surgical Gut Suture
    Manufacturer
    COVIDIEN
    Date Cleared
    2015-01-29

    (133 days)

    Product Code
    GAL
    Regulation Number
    878.4830
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K885018
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Plain, Chromic and Mild Chromic gut absorbable sutures are in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in microsurgery, cardiovascular or neurological surgery.

    Device Description

    Covidien's surgical gut sutures are absorbable sterile surgical sutures composed of purified connective tissue (mostly collagen) derived from the serosal layer of bovine intestines. They are packaged in a solution of 87% isopropanol, 12% water and 1% triethanolamine.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document describes a 510(k) submission for an absorbable surgical gut suture and details its intended use, characteristics, materials, and performance data, but it does not specify acceptance criteria, study results in the format of a table, sample sizes for test or training sets, data provenance, expert qualifications, or details about MRMC studies. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study against specific acceptance criteria.

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