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510(k) Data Aggregation

    K Number
    K001807
    Device Name
    TISSUE MARKER
    Manufacturer
    ADVANCED UROSCIENCE, INC.
    Date Cleared
    2001-05-03

    (322 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED UROSCIENCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002573
    Device Name
    ADVANCED UROSCIENCE INNERSHEATH
    Manufacturer
    ADVANCED UROSCIENCE, INC.
    Date Cleared
    2000-11-16

    (90 days)

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

    ADVANCED UROSCIENCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Advanced UroScience InnerSheath is indicated for use to help position an injection needle within the center of an endoscope.
    Device Description
    Advanced UroScience InnerSheath consists of a cannula and a cap. The cannula is designed to fit easily within an endoscope and to permit easy alignment of an injection needle within to in easily within an endosope and to provide adequate gripping of the cannula and endoscope, and an adequate seal with the injection needle. Advanced UroScience InnerSheath is provided sterile and is intended for single use only.
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    K Number
    K002323
    Device Name
    ADVANCED UROSCIENCE INJECTION NEEDLE
    Manufacturer
    ADVANCED UROSCIENCE, INC.
    Date Cleared
    2000-07-31

    (34 days)

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

    ADVANCED UROSCIENCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993459
    Device Name
    MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
    Manufacturer
    ADVANCED UROSCIENCE, INC.
    Date Cleared
    1999-11-05

    (23 days)

    Product Code
    PAG
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED UROSCIENCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in the treatment of hernias where the connective tissue has ruptured or as a sling material to support the repositioning and support of the bladder neck for female urinary incontinence resulting from urethral hypermobility or sphincter deficiency.
    Device Description
    [Trade name] is a sterile, processed and treated porcine skin, which is intended for use in the reconstruction of soft tissue deficiencies.
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    K Number
    K982890
    Device Name
    ADVANCED UROSCIENCE INJECTION NEEDLE
    Manufacturer
    ADVANCED UROSCIENCE, INC.
    Date Cleared
    1998-10-26

    (70 days)

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

    ADVANCED UROSCIENCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Advanced UroScience Injection needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure.
    Device Description
    The Advanced UroScience Injection Needle consists of a stainless steel needle attached to a plastic luer lock hub. Needle length ranges up to 200 cm to accommodate the length of the endoscope channel and gauge ranges from 14 to 25. The needle length and gauge will be identified on the label. The luer lock hub, which is molded onto the needle, is designed to accommodate a standard syringe. The Advanced UroScience Injection Needle is intended for use as an accessory for currently marketed endoscopes and provides delivery of injectable materials during an endoscopic procedure. The type of material to be injected is dependent on the nature of the procedure, but may include delivery of collagen during cystoscopic procedures, sclerosing agents during esophagoscopic and gastroscopic procedures, local anesthetics during cystoscopic or laryngoscopic procedures, or saline or contrast media during colonoscopic procedures. The Advanced UroScience Injection Needle is provided sterile and is intended for single use only.
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