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510(k) Data Aggregation

    K Number
    K033644
    Device Name
    ENDOBOY
    Manufacturer
    GEYSER S.A.
    Date Cleared
    2004-03-24

    (125 days)

    Product Code
    GCJ,GJC
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    GEYSER S.A.

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

    The ENDOBOY is a holding and manipulating arm for use in surgery that allows the operating team to hold surgical instruments in a given position and to change that position immediately with one hand

    Device Description

    The ENDOBOY is a holding and manipulating arm for use in surgery

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "Endoboy Surgical Instrument Holder."

    This document does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the FDA has reviewed the 510(k) premarket notification and found the device substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

    Key information missing from the document that would be needed to answer your request includes:

    • Performance data: There are no reported device performance metrics.
    • Study details: No information on a study design, sample sizes, ground truth establishment, or expert involvement is present.
    • Acceptance criteria: No specific acceptance criteria are listed for the device's performance.

    Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and the study, as the provided input does not contain this information.

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