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510(k) Data Aggregation

    K Number
    K062458
    Device Name
    ETHMOID SINUS SPACER
    Manufacturer
    ACCLARENT, INC.
    Date Cleared
    2006-09-15

    (23 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 :

    ETHMOID SINUS SPACER

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

    The Ethmoid Sinus Spacer is indicated for use as a postoperative spacer to maintain an opening to the ethmoid sinus within the first 14 days following surgery. The Ethmoid Sinus Spacer also helps to prevent obstruction.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The document is solely a regulatory approval notice.

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