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510(k) Data Aggregation

    K Number
    K002261
    Device Name
    MR-III
    Manufacturer
    SMITH & NEPHEW, INC.
    Date Cleared
    2000-10-23

    (90 days)

    Product Code
    GAS
    Regulation Number
    878.5000
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K925573,K942442
    Why did this record match?
    Device Name :

    MR-III

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

    MR-III is intended for use as a suture retention device to facilitate pecutaneous or endoscopic soft tissue repair.

    The indications for the MR-III are for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair and gastrostomy.

    Device Description

    The MR-III is a suture retention device manufactured from polyester suture, polyacetal bar, stainless steel needle and a plastic handle.

    AI/ML Overview

    The provided text is a 510(k) summary for the MR-III Suture Retention Device. It does not contain information about acceptance criteria, device performance metrics, or details of a study used to prove the device meets acceptance criteria. The document primarily focuses on the administrative aspects of a 510(k) submission, including company contact, device description, predicate devices, and intended use as well as the FDA's decision letter. Studies proving performance are not part of the 510(k) Summary. Therefore, I cannot generate the requested table and study details from the provided input.

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