LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K973152
    Device Name
    GALLINI ABS DEVICE
    Manufacturer
    GALLINI U.S., LLC.
    Date Cleared
    1998-01-09

    (140 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GALLINI ABS DEVICE

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

    The instrument is designed to be used for high-speed histological biopsy.

    Device Description

    ABS® Device

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA to Gallini U.S., L.L.C. for their "Gallini ABS Device" (K973152). It indicates that the device has been found substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

    The letter is a notification of substantial equivalence, which primarily means the FDA believes the device is as safe and effective as a legally marketed device and can be cleared for market. It does not typically include detailed performance study results or acceptance criteria within the letter itself. Such information would usually be found in the 510(k) submission document, which is not provided here.

    Therefore, I cannot provide the requested information based on the given text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1