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510(k) Data Aggregation

    K Number
    K971621
    Device Name
    RESISTICK SOLID LAPAROSCOPIC ELECTRODES
    Manufacturer
    AARON MEDICAL INDUSTRIES
    Date Cleared
    1997-06-20

    (50 days)

    Product Code
    KNF
    Regulation Number
    884.4160
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    K984239
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The subject device of this premarket notification submission is indicated for use to cut and or coagulate during laparoscopic surgical procedures.

    Device Description

    Resistick Solid Laparoscopic Electrodes

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device (Resistick Solid Laparoscopic Electrodes) that was issued in 1997. It explicitly states that the device is substantially equivalent to devices marketed prior to 1976.

    Therefore, this document does not contain any information about acceptance criteria, study performance, or AI/software validation studies. These types of studies and the regulatory framework around them, especially for AI/ML devices, did not exist at the time this clearance was issued.

    The document only confirms that the FDA reviewed the submission and determined that the device is "substantially equivalent" to predicate devices, allowing it to be marketed.

    To answer your request, I would need a different type of document, specifically a more recent regulatory submission or clinical study report for an AI-powered medical device.

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