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510(k) Data Aggregation

    K Number
    K121337
    Device Name
    UROPLASTY RIGID ENDOSCPIC NEEDLES
    Manufacturer
    UROPLASTY, INC.
    Date Cleared
    2012-08-03

    (92 days)

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

    UROPLASTY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Uroplasty Rigid Endoscopic Needles are accessories to currently marketed endoscopes allowing delivery of injectable material into tissues during an endoscopic procedure. The Uroplasty Rigid Endoscopic Needles may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials. The type of material to be injected will be dependent on the nature of the endoscopic procedure. Possible injectable materials include: tissue bulking agents; sclerosing agents; local anesthetics; saline; or contrast media.
    Device Description
    The Uroplasty Rigid Endoscopic Needle is an accessory for endoscopes with a working channel inner diameter of 4 French or larger. The Rigid Endoscopic Needle is supplied sterile and is intended for single use only. The Rigid Endoscopic Needle is comprised of a stainless steel cannula 300 - 500 mm in length with an 18-23 gauge tip (10 - 15 mm in length) and a copolyester Luer lock hub.
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    K Number
    K101847
    Device Name
    URGENT PC STIMULATOR; URGENT PC LEAD SET
    Manufacturer
    UROPLASTY, INC.
    Date Cleared
    2010-10-21

    (112 days)

    Product Code
    NAM
    Regulation Number
    876.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    UROPLASTY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Urgent PC Neuromodulation System is intended to treat patients with Overactive Bladder (OAB) and associated symptoms of urinary urgency, urinary frequency, and urge incontinence.
    Device Description
    The Urgent® PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS). The Urgent PC Neuromodulation System is a combination of the Urgent PC Stimulator and the Urgent PC Stimulation Lead Set. The Urgent PC Stimulator is a battery-operated external pulse generator and is designed, constructed, and manufactured for multiple use, only in conjunction with the Urgent PC Stimulation Lead Set. The Urgent PC Stimulation Lead Set transfers the electrical current from the Urgent PC Stimulator to the tibial nerve via the Needle Electrode. The entire Stimulation Lead Set is intended for single use only and is not to be reused.
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    K Number
    K091391
    Device Name
    UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518
    Manufacturer
    UROPLASTY, INC.
    Date Cleared
    2009-06-30

    (50 days)

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

    UROPLASTY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Uroplasty Rigid Endoscopic Needle is an accessory to currently marketed endoscopes allowing delivery of injectable material into tissues during an endoscopic procedure. The Uroplasty Rigid Endoscopic Needle may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials. The type of material to be injected will be dependent on the nature of the endoscopic procedure. Possible injectable materials include: tissue bulking agents; sclerosing agents; local anesthetics; saline; or contrast media.
    Device Description
    The Uroplasty Rigid Endoscopic Needle is an accessory for endoscopes with a working channel inner diameter of 4 French or larger. The Rigid Endoscopic Needle is supplied sterile and is intended for single use only. The stainless steel cannula is 300 to 500 mm long with an 18-23 gauge tip (10 - 15 mm in length) and a metal luer lock connector; the needle also has a protective polyethylene sheath.
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    K Number
    K071822
    Device Name
    URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12
    Manufacturer
    UROPLASTY, INC.
    Date Cleared
    2007-08-20

    (48 days)

    Product Code
    NAM
    Regulation Number
    876.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    UROPLASTY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Urgent PC Neuromodulation System is intended to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence.
    Device Description
    The Urgent® PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS). The Urgent PC Neuromodulation System is a combination of the Urgent PC Stimulator and the Urgent PC Stimulation Lead Set. The Urgent PC Stimulator is a battery-operated external pulse generator and is designed, constructed, and manufactured for multiple use, only in conjunction with the Urgent PC Stimulation Lead Set. The Urgent PC Stimulation Lead Set transfers the electrical current from the Urgent PC Stimulator to the tibial nerve via the Needle Electrode. The entire Stimulation Lead Set is intended for single use only and is not to be reused.
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    K Number
    K061333
    Device Name
    URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12
    Manufacturer
    UROPLASTY, INC.
    Date Cleared
    2006-07-03

    (52 days)

    Product Code
    NAM
    Regulation Number
    876.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    UROPLASTY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Urgent PC Neuromodulation System is intended to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence.
    Device Description
    The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS). The Urgent PC Neuromodulation System is a combination of the Urgent PC Stimulator and the Urgent PC Stimulation Lead Set. The Urgent PC Stimulator is a battery-operated external pulse generator and is designed, constructed, and manufactured for multiple use, only in conjunction with the Urgent PC Stimulation Lead Set. The Urgent PC Stimulation Lead Set transfers the electrical current from the Urgent PC Stimulator to the tibial nerve via the Needle Electrode. The entire Stimulation Lead Set is intended for single use only and is not to be reused.
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    K Number
    K052025
    Device Name
    URGENT PC NEUROMODULATION SYSTEM
    Manufacturer
    UROPLASTY, INC.
    Date Cleared
    2005-10-17

    (82 days)

    Product Code
    NAM
    Regulation Number
    876.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    UROPLASTY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Urgent PC Neuromodulation System is intended to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence.
    Device Description
    The Urgent® PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS). The Urgent PC Neuromodulation System is a combination of the Urgent PC Stimulator and the Urgent PC Stimulation Lead Set. The Urgent PC Stimulator is a battery-operated external pulse generator and is designed, constructed, and manufactured for multiple use, only in conjunction with the Urgent PC Stimulation Lead Set. The Urgent PC Stimulation Lead Set transfers the electrical current from the Urgent PC Stimulator to the tibial nerve via the Needle Electrode. The entire Stimulation Lead Set is intended for single use only and is not to be reused.
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    K Number
    K052175
    Device Name
    I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000
    Manufacturer
    UROPLASTY, INC.
    Date Cleared
    2005-10-17

    (68 days)

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

    UROPLASTY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The I-STOP Mid-Urethral Sling is intended for the treatment of female stress urinary incontinence (SUI) due to urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
    Device Description
    The I-STOP Device is comprised of a non-resorbable polypropylene material woven into a mesh with each end attached to a polyethylene clip, two technique-dependant stainless steel implantation needles and two polycarbonate needle handles. The device is EtO sterilized and intended for single-use only.
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    K Number
    K051905
    Device Name
    UROPLASTY RIGID ENDOSCOPIC NEEDLE
    Manufacturer
    UROPLASTY, INC.
    Date Cleared
    2005-08-29

    (46 days)

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

    UROPLASTY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Uroplasty Rigid Endoscopic Needle is an accessory to currently marketed endoscopes allowing delivery of injectable material into tissues during an endoscopic procedure. The Uroplasty Rigid Endoscopic Needle may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials. The type of material to be injected will be dependent on the nature of the endoscopic procedure. Possible injectable materials include: tissue bulking agents; sclerosing agents; local anesthetics; saline; or contrast media.
    Device Description
    The Uroplasty Rigid Endoscopic Needle is an accessory for endoscopes with a working channel inner diameter of 5 French or larger. The Rigid Endoscopic Needle is supplied sterile and is intended for single use only. The 5 French stainless steel cannula is 380 to 500 mm long with an 18-gauge tip (10 mm in length) and a metal luer lock connector; the needle also has a protective polyethylene sheath.
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