LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K040842
    Device Name
    SENORX BIOPSY DEVICE II
    Manufacturer
    SENORX, INC.
    Date Cleared
    2004-04-30

    (29 days)

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

    SENORX BIOPSY DEVICE II

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

    The SenoRx Biopsy Device II is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is intended to provide breast tissue samples where there is partial or complete removal of the imaged abnormality.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the SenoRx Biopsy Device II. It primarily discusses the regulatory approval, substantial equivalence, and general controls applicable to the device. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the detailed study parameters requested in the prompt.

    Therefore, I cannot fulfill the request using only the provided text. The document is a regulatory communication, not a performance study report.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1