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510(k) Data Aggregation

    K Number
    K980623
    Device Name
    N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPE
    Manufacturer
    N-TECH ENDOSCOPY, INC.
    Date Cleared
    1998-04-30

    (72 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPE

    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

    I am sorry, but the provided text does not contain any information about acceptance criteria for a device, a study that proves a device meets acceptance criteria, or any of the detailed study parameters requested (sample size, data provenance, expert ground truth, adjudication method, MRMC studies, standalone performance,  ground truth type, or training set details).

    The document is an FDA 510(k) clearance letter for an "N" Tech Double Puncture Laparoscope/"N" Tech Operating Laparoscope (Autoclavable). It states that the device is substantially equivalent to legally marketed predicate devices and outlines the general controls and regulations it is subject to. It also includes the intended "Indications for Use" for the laparoscopes.

    There is no scientific study or performance data described within this document.

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