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510(k) Data Aggregation

    K Number
    K003949
    Device Name
    TACKER, MODEL R65-933
    Manufacturer
    A & A MEDICAL, INC.
    Date Cleared
    2001-07-25

    (216 days)

    Product Code
    OCW,GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K113543,K072702,K043232
    Why did this record match?
    Device Name :

    TACKER, MODEL R65-933

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

    THIS DEVICE IS INDICATED for USE IN ENDOSCOPIC SURGERY PROCEDURES for URETHROPEXY, INCLUDING FIXATION OF PROSTATIC MATERIAL, APPROXIMATION of TISSUES IN VARIOUS SURGICAL SPECIALTIES, SUCH AS REPAIR OF HERNIAS AND BLADDER NECK SUSPENSION

    Device Description

    The Tacker is a device that consists of one disposable component and two permanently implantable components. The disposable component is a 45cm long stainless steel tube. The first permanently implantable component is a helical fastener. The second permanently implantable component is a PROLENE nonabsorbable "O" suture. The instrument is designed for introduction and use through an appropriately sized trocar sleeve or larger with the use of an appropriate seal.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device called "Tacker." It describes the device, its intended use, and claims substantial equivalence to another marketed device. However, it does not include a study that details acceptance criteria and device performance in a way that allows for filling out the requested information.

    Specifically, the text is a regulatory submission for premarket notification, focused on demonstrating substantial equivalence to a predicate device based on design and intended use, rather than presenting a detailed clinical study with performance metrics against acceptance criteria.

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

    Reasoning for inability to answer:

    The document focuses on:

    • Regulatory notification: It's a 510(k) submission to the FDA.
    • Substantial equivalence: It claims the device is "substantially equivalent" to a predicate device, which is a regulatory pathway, not a performance study result.
    • Device description and intended use: It provides details about the Tacker and its indications for use.
    • Absence of study details: There is no mention of specific studies, acceptance criteria, results, sample sizes, expert qualifications, ground truth, or MRMC studies that would allow for the detailed table and answers requested.
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