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    K Number
    K061555
    Device Name
    ANCHOR LAPARSCOPIC TISSUE RETIEVAL SYSTEM
    Manufacturer
    ANCHOR PRODUCTS CO.
    Date Cleared
    2006-08-31

    (87 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ANCHOR LAPARSCOPIC TISSUE RETIEVAL SYSTEM

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

    The Anchor Tissue retrieval system is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Anchor Tissue Retrieval System. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    The document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically found in a study report for an AI/ML device.

    Therefore, I cannot provide the requested information based on the text provided. This FDA letter is primarily a regulatory approval document based on substantial equivalence, not a detailed technical report of a study proving performance against defined acceptance criteria.

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