LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K992480
    Device Name
    MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES
    Manufacturer
    MEDIFIX, INC.
    Date Cleared
    1999-09-23

    (59 days)

    Product Code
    HET,GCJ
    Regulation Number
    884.1720
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES

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

    Laparoscopes, both the single and double puncture are for use when Gynecological Pelviscopy and Laparoscopic Cholecystectomy are medically indicated.

    Device Description

    Not Found

    AI/ML Overview

    This document is a letter from the FDA regarding a medical device, specifically a "Medifix Single and Double Puncture Laparoscope." It states that the device has been reviewed and determined to be "substantially equivalent" to devices marketed prior to May 28, 1976. This letter is a clearance to market the device.

    However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details.

    The letter is primarily a regulatory communication confirming that the device can be legally marketed based on its substantial equivalence to existing devices. It does not delve into the technical validation and performance metrics typically associated with studies that establish acceptance criteria for a new or modified device.

    Therefore, I cannot fulfill your request for the detailed information because it is not present in the provided document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1