Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K230778
    Device Name
    EndoCore
    Manufacturer
    Praxis Medical, LLC
    Date Cleared
    2023-09-25

    (188 days)

    Product Code
    KTI
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    Praxis Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Praxis Medical EndoCore is used with ultrasound endoscope to sample targeted submucosal and extramural lesions of the tracheobronchial tree. For any patient 18 years and older - requiring tissue sampling.
    Device Description
    The EndoCore is intended to be used with endoscopes for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree.
    Ask a Question
    K Number
    K200278
    Device Name
    CytoCore
    Manufacturer
    Praxis Medical, LLC
    Date Cleared
    2020-03-31

    (56 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    Praxis Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CytoCore is a device to hold a syringe for performing a biopsy of an identified mass with one hand.
    Device Description
    The Praxis Medical CytoCore is a syringe-holding device for performing a biopsy of soft tissue for diagnostic sampling. It is equipped with a scissor-slide mechanism for drawing back the syringe plunger to create suction, and an internal motor oscillates the needle to facilitate cellular material harvesting. The device places the hand relatively close to the needle tip while the hand is in a position of natural function, providing greater tactile sensation of the texture of the lesion and enabling accurate needle placement using fine motor control of the hand. The device enables an operator to place a needle into a target area to harvest cells.
    Ask a Question

    Page 1 of 1