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510(k) Data Aggregation

    K Number
    K091135
    Device Name
    RUTTER SUPRA STOMAL STENTS
    Manufacturer
    BOSTON MEDICAL PRODUCTS, INC.
    Date Cleared
    2009-09-14

    (147 days)

    Product Code
    FWN
    Regulation Number
    874.3620
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RUTTER SUPRA STOMAL STENTS

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

    The Rutler Supra Stomal Stent is indicated for the prevention and treatment of laryngeal and tracheal stenosis.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) substantially equivalent letter from the FDA regarding the "Rutter Supra Stomal Stents." It does not contain information about acceptance criteria, device performance metrics, or study details. It is a regulatory approval letter.

    Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and the substantial equivalence determination, not on a detailed scientific study supporting device performance.

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