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Found 8 results
510(k) Data Aggregation
K Number
K121337Device Name
UROPLASTY RIGID ENDOSCPIC NEEDLES
Manufacturer
UROPLASTY, INC.
Date Cleared
2012-08-03
(92 days)
Product Code
FBK
Regulation Number
876.1500Why 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
K101847Device Name
URGENT PC STIMULATOR; URGENT PC LEAD SET
Manufacturer
UROPLASTY, INC.
Date Cleared
2010-10-21
(112 days)
Product Code
NAM
Regulation Number
876.5310Why 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
K091391Device Name
UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518
Manufacturer
UROPLASTY, INC.
Date Cleared
2009-06-30
(50 days)
Product Code
FBK
Regulation Number
876.1500Why 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
K071822Device 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
876.5310Why 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
K061333Device 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
876.5310Why 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
K052025Device Name
URGENT PC NEUROMODULATION SYSTEM
Manufacturer
UROPLASTY, INC.
Date Cleared
2005-10-17
(82 days)
Product Code
NAM
Regulation Number
876.5310Why 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
K052175Device 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
878.3300Why 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
K051905Device Name
UROPLASTY RIGID ENDOSCOPIC NEEDLE
Manufacturer
UROPLASTY, INC.
Date Cleared
2005-08-29
(46 days)
Product Code
FBK
Regulation Number
876.1500Why 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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