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510(k) Data Aggregation

    K Number
    K050340
    Device Name
    MICROMEDICS SPHENOID SINUS STENT
    Manufacturer
    MICROMEDICS, INC.
    Date Cleared
    2005-04-27

    (75 days)

    Product Code
    KAM
    Regulation Number
    878.4800
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MICROMEDICS SPHENOID SINUS STENT

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

    Intended for use as a postoperative stent to maintain an opening to the sphenoid sinus, during the first 14 days following surgery and helps prevent obstruction by adhesions.

    Device Description

    Sphenoid Sinus Stent

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Micromedics Sphenoid Sinus Stent. It primarily establishes substantial equivalence to a predicate device and outlines regulatory compliance requirements. It does not contain the acceptance criteria, study details, or performance data asked for in the prompt.

    Therefore, an answer fulfilling all requirements of the prompt cannot be generated from the provided text. The document acts as a regulatory approval, not a scientific study report.

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