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510(k) Data Aggregation

    K Number
    K980676
    Device Name
    SPIGAL NEEDLE
    Manufacturer
    GALLINI U.S., LLC.
    Date Cleared
    1998-05-21

    (90 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 :

    SPIGAL NEEDLE

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

    This device is to be used for spinal biopsies.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device called the "Spigal Needle." It confirms the device's substantial equivalence to previously marketed devices.

    This document does not contain information about:

    • Acceptance criteria and reported device performance in a table.
    • Details of any study, including sample sizes, data provenance, expert qualifications, or adjudication methods for ground truth.
    • Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
    • The type of ground truth used or details about training sets.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is solely an FDA clearance letter.

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