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510(k) Data Aggregation

    K Number
    K012923
    Device Name
    ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201
    Manufacturer
    ARTHREX, INC.
    Date Cleared
    2001-10-04

    (34 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K010673,K003590,K990088,K000540,K001434,K001172
    Why did this record match?
    Device Name :

    ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201

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

    The Arthrex Fiberwire™USP size 5 suture is intended for use in soft tissue approximation and or ligation.

    Device Description

    Arthrex, Inc. Fiberwire™ suture is 38 " in length and has a diameter of 0.700 to 0.799 mm. It is made of long chain polyesters which are braided and sterilized and for surqical use. It is available in dyed and non-dyed varieties, with or without needles.

    AI/ML Overview

    The provided document is a 510(k) summary for a surgical suture (Arthrex Fiberwire™ USP size 5 suture). It does NOT contain information about acceptance criteria, device performance studies, or AI/software validation.

    Therefore, I cannot provide the requested information. The document focuses on establishing substantial equivalence to predicate devices based on basic features and intended use, rather than detailed performance studies with acceptance criteria commonly found for AI/imaging devices.

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