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510(k) Data Aggregation

    K Number
    K041159
    Device Name
    JMS ABSORBABLE ANCHOR AND APPLICATOR
    Manufacturer
    JMS, INC.
    Date Cleared
    2004-07-27

    (85 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    JMS, INC.

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

    The Absorbable Anchor™ and Applicator are indicated for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.

    Device Description

    Absorbable Anchor™ and Applicator

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the Absorbable Anchor™ and Applicator. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

    The letter only confirms the regulatory clearance based on substantial equivalence to existing devices. Details about specific performance metrics, clinical trials, sample sizes, ground truth establishment, or expert evaluations are not present in this document.

    Therefore, I cannot provide the requested information from the given text.

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