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510(k) Data Aggregation

    K Number
    K974446
    Device Name
    MANAN AUTOMATIC CUTTING NEEDLE
    Manufacturer
    MANAN MEDICAL PRODUCTS, INC.
    Date Cleared
    1998-01-08

    (44 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 :

    MANAN AUTOMATIC CUTTING NEEDLE

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

    Needle can be used for obtaining core and/or aspiration biopsies of various tissues (Prostate, lung, kidney, liver, spleen, thyroid, adrenals, abdominal soft tissue masses, breast). For Breast Biopsy this product is for diagnosis only-not for therapeutic use.

    Device Description

    Automatic Cutting Needle

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Manan Automatic Cutting Needle." It indicates that the device has been found substantially equivalent to a predicate device already on the market.

    However, the letter does not contain any information regarding specific acceptance criteria, study details, or performance data for the device. It primarily focuses on the regulatory clearance process and the device's classification.

    Therefore, I cannot provide the requested information in the table or answer the specific questions about acceptance criteria and study details based on the provided text. The document is a regulatory approval letter, not a technical report or study summary.

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