LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K140101
    Device Name
    ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS
    Manufacturer
    ABMEDICA SAS
    Date Cleared
    2014-07-10

    (176 days)

    Product Code
    GCJ,GEI
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The abMedica Reusable Laparoscopic Hand Instruments and Trocars are indicated for use in adult and pediatric diagnostics and therapeutic general endoscopy and laparoscopic surgery.

    Device Description

    Reusable Laparoscopic Hand Instruments and Trocars

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding "Reusable Laparoscopic Hand Instruments and Trocars." It discusses the device's substantial equivalence to legally marketed predicate devices and outlines regulatory requirements.

    However, this document does NOT contain information about acceptance criteria, device performance, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI/ML powered medical device.

    The document is a regulatory approval letter for a traditional medical device (surgical tools), not an AI/ML product. Therefore, I cannot extract the requested information as it is not present in the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1