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510(k) Data Aggregation

    K Number
    K032965
    Device Name
    LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE
    Manufacturer
    MODERN MEDICAL EQUIPMENT MFG., LTD.
    Date Cleared
    2004-05-13

    (233 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE

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

    Be commonly used in Minimally Invasive Surgery for coagulation and cutting of tissue.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a Laparoscopic Instrument, Electrode, and Cable. It states that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information regarding:

    • Acceptance criteria and reported device performance.
    • Details of any study (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods).
    • MRMC comparative effectiveness study results.
    • Standalone algorithm performance.

    The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This indicates that the regulatory review was based on the submitted 510(k) notification, which would have contained the study information. However, the study details themselves are not present in this clearance letter.

    Therefore, I cannot provide the requested information based on the provided text.

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