LogoFDA 510(k) Search
Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K090830
    Device Name
    LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES, LTD.
    Date Cleared
    2009-07-21

    (117 days)

    Product Code
    FBK
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    LABORIE MEDICAL TECHNOLOGIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The injeTak™ Adjustable Tip Needles are intended to be used to deliver a variety of legally marketed drugs into tissues or structures during cystoscopic procedures. They are provided sterile and single use only.
    Device Description
    The injeTAK'" Adjustable Tip Needle consists of a metal needle cannula and an outer movable sheath with an attached adjusting mechanism. The needle sheath diameter is 6Fr with 35-50cm in length, The stainless steel needle is 25gauge Needle tip length adjusting mechanism is used to adjust & set the relative distance between the distal needle point to the distal end tip of needle sheath in a range of 0-5 millimeter (mm). Numbers (0, 2, 3, 5) printed on handle of the adjusting mechanism are used to indicate the individual needle tip (penetration) lengths in millimeter (mm) unit.
    Ask a Question
    K Number
    K962009
    Device Name
    UROSTYM
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES, LTD.
    Date Cleared
    1997-05-20

    (363 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    LABORIE MEDICAL TECHNOLOGIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Laborie UROSTYM™ is intended to be used in treating urinary incontinence (stress incontinence (hypermobility) and bladder instability) by way of perineal reeducation. Using the available accessories, the system can be used for performing biofeedback and electro-stimulation therapy as treatment modalities for urinary incontinence.
    Device Description
    UROSTYM™ Biofeedback and Stimulation Device
    Ask a Question
    K Number
    K955856
    Device Name
    TEX-AID BLUE
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES, LTD.
    Date Cleared
    1996-02-16

    (52 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Why did this record match?
    Applicant Name (Manufacturer) :

    LABORIE MEDICAL TECHNOLOGIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K955810
    Device Name
    U-TEX
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES, LTD.
    Date Cleared
    1996-01-24

    (29 days)

    Product Code
    FHA
    Regulation Number
    876.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    LABORIE MEDICAL TECHNOLOGIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1