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510(k) Data Aggregation

    K Number
    K020480
    Device Name
    RBM
    Manufacturer
    SMITH & NEPHEW, INC.
    Date Cleared
    2002-03-12

    (27 days)

    Product Code
    KGS,GAT
    Regulation Number
    878.4930
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K002261
    Predicate For
    K072322
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The RBM is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue repair. The indications for the RBM are for use as a suture retention device to facilitate percuraneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repar), rotator cuff repair, meniscal repair, and gastrostomy.

    Device Description

    The RBM is a suture retention device manufactured from polyester suture, poly(L-lactide) bar, stainless steel needle and a plastic handle.

    AI/ML Overview

    The provided text is a 510(k) summary for the RBM suture retention device. It describes the device, its intended use, and compares it to a predicate device (MR-III). However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory submission for substantial equivalence based on technological characteristics and intended use alignment with a predicate device, rather than performance testing against specific acceptance criteria.

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