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510(k) Data Aggregation

    K Number
    K060414
    Device Name
    KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE
    Manufacturer
    KMI KOLSTER METHODS, INC.
    Date Cleared
    2006-10-23

    (249 days)

    Product Code
    GAW,GAM
    Regulation Number
    878.5010
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE

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

    The Featherlift silhouette Suture is indicated for use in mid-face suspension surgery to fixate the cheek sub dermis in an elevated position.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for the "Featherlift Silhouette Suture." It confirms that the device is substantially equivalent to a legally marketed predicate device. This type of regulatory document does not contain acceptance criteria or a study describing device performance.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than technical performance data.

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