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510(k) Data Aggregation

    K Number
    K111986
    Device Name
    LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM
    Manufacturer
    SURGICAL INNOVATIONS PLC
    Date Cleared
    2012-01-26

    (197 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 :

    LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM

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

    The Logic Laparoscopic Instrument System, Electrosurgical, Cutting & Coagulation & Accessories is designed to dissect, grasp, manipulate and/or cauterise various tissues during manual operations in minimally invasive surgery and general endoscopic/laparoscopic procedures.

    Device Description

    Logic Laparoscopic Instrument System, Electrosurgical, Cutting & Coagulation & Accessories

    AI/ML Overview

    This is an FDA 510(k) clearance letter for the "Logic Laparoscopic Instrument System". It states that the device is substantially equivalent to legally marketed predicate devices. The letter itself does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to provide detailed performance studies with acceptance criteria in the same way a PMA (Premarket Approval) submission would.

    Therefore, I cannot extract the requested information from the provided text. The document is a regulatory clearance letter, not a detailed study report.

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