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510(k) Data Aggregation

    K Number
    K983122
    Device Name
    MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT
    Manufacturer
    MILL-ROSE LABORATORY
    Date Cleared
    1998-10-30

    (52 days)

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

    MILL-ROSE LABORATORY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Transbronchial Needle Aspiration Combination Cytology/Histology Procedural Kit is intended to retrieve and handle specimens and to prepare them for proper cytopathic and histological examination.
    Device Description
    The Transbronchial Needle Aspiration Combination Cytology/Histology Procedural Kit contains items for obtaining and handling of cytologic and histological specimens in the context of a transbronchial aspirating needle procedure.
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    K Number
    K983124
    Device Name
    MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT
    Manufacturer
    MILL-ROSE LABORATORY
    Date Cleared
    1998-10-30

    (52 days)

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

    MILL-ROSE LABORATORY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Transbronchial Needle Aspiration Cytology Procedural Kit is intended to retrieve and handle specimens and to prepare them for proper cytopathic examination.
    Device Description
    The Transbronchial Needle Aspiration Cytology Procedural Kit contains items for obtaining and handling of cytologic specimens in the context of a transbronchial aspirating needle procedure.
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    K Number
    K971275
    Device Name
    MILL-ROSE DISPOSABLE POLYPECTOMY SNARE
    Manufacturer
    MILL-ROSE LABORATORY
    Date Cleared
    1997-05-23

    (46 days)

    Product Code
    FDI
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MILL-ROSE LABORATORY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the subject device is to electrosurgically remove GI tract polyps through the channel of an endoscope
    Device Description
    The device consists of a handle, cable, snare loop and cable. The loop is attached to the handle assembly by means of the cable. The sheath is also connected to the handle assembly and collapses the loop upon its retraction into the sheath.
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    K Number
    K962736
    Device Name
    MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE
    Manufacturer
    MILL-ROSE LABORATORY
    Date Cleared
    1996-07-29

    (14 days)

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

    MILL-ROSE LABORATORY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to be used through a laryngoscope for the therapeutic injection the larynx for various laryngeal disorders such as paralysis, tissue deficiency, contact ulcers and spasmodic dysphonia.
    Device Description
    The device consists of an outer catheter and an inner catheter to which a needle is mounted. The inner catheter slides within the outer catheter such that the needle tip may advance a pre-determined distance past the end of the outer catheter and remains totally within the lumen catheter when the needle is fully retracted.
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    K Number
    K960880
    Device Name
    MILL-ROSE BLIND MICROBIOLOGY BRUSH
    Manufacturer
    MILL-ROSE LABORATORY
    Date Cleared
    1996-04-29

    (56 days)

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

    MILL-ROSE LABORATORY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to allow blind, non-directed, protected specimen brush sampling of the lower respiratory tract secretions or to perform surveillance cultures or to diagnose pneumonia in patients receiving mechanical ventilation.
    Device Description
    The subject device is sterile and consists of a flexible polymeric inner sheath which is contained within an outer sheath. Within the inner sheath is a twisted wire brush. The outer sheath is occluded with a polyethylene glycol wax plug. Upon use, the inner sheath is advanced, the plug expelled and the brush advanced to provide a sterile, non-contaminated specimen brush.
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