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510(k) Data Aggregation

    K Number
    K980226
    Device Name
    MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEM
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Date Cleared
    1998-02-18

    (27 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K895897,K914874,K921418
    Why did this record match?
    Device Name :

    MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEM

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

    The Manan™ Pro-Mag Automatic Biopsy System is used to obtain multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.

    Device Description

    The Manan™ Pro-Mag Automatic Biopsy System is used to obtain multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.

    AI/ML Overview

    The provided document is a 510(k) summary for the Manan™ Pro-Mag Automatic Biopsy System. It focuses on establishing substantial equivalence to previously marketed devices and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

    Therefore, I cannot extract the requested information, which typically pertains to performance studies demonstrating the effectiveness and safety of a device against predefined metrics. This document is a regulatory filing, not a clinical or performance study report.

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