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Found 18 results
510(k) Data Aggregation
K Number
K162992Device Name
Karl Storz UROMAT E.A.S.I.
Manufacturer
KARL STORZ ENDOSCOPY AMERICA, INC
Date Cleared
2017-07-07
(253 days)
Product Code
LJH
Regulation Number
876.5130Why did this record match?
Product Code :
LJH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UROMAT E.A.S.I. is used for the introduction of irrigation fluids into organs and operating fields as well as the suctioning off of irrigation and bodily fluids, secretions and tissue during endoscopic interventions.
Device Description
The UROMAT E.A.S.I. is a peristaltic (double roller), microprocessor controlled, irrigation and suction pump with continuous fluid flow for urological interventions. Alternatively, the two pumps can be flowoperated independently of each other for flow regulation, e.g., for laparoscopic interventions.
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K Number
K070873Device Name
AMSURE BLADDER IRRIGATION SET
Manufacturer
AMSINO INTL., INC.
Date Cleared
2007-12-19
(265 days)
Product Code
LJH
Regulation Number
876.5130Why did this record match?
Product Code :
LJH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AMSure® Bladder Irrigation Set is intended for the infusion of fluids to evacuate the bladder. It is also indicated for use in such procedures as cystoscopies and transurethral-resections as a means of continuous bladder irrigation.
Device Description
The AMSure™ Bladder Irrigation Set is comprised of tubing with a catheter adapter at one end and “spikes” with protectors on the other end. The device is available in a single-lead (single spike), or multiple-lead (2 or 4 spikes) configuration. All configurations have a drip chamber and directly below the drip chamber is a roller clamp. There is a flexible, non-latex, synthetic rubber connecting tube, attached to the catheter adapter.
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K Number
K071832Device Name
MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM
Manufacturer
MEDICAL SCIENTIFIC, INC.
Date Cleared
2007-09-18
(77 days)
Product Code
LJH, KOG
Regulation Number
876.5130Why did this record match?
Product Code :
LJH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To provide irrigation during endoscopic surgical procedures
Device Description
Spyglass is an irrigation system for Endoscopy. This system is a peristaltic pump for delivering sterile water or saline through an endoscope (or catheter) for rinsing substances such as blood or bile from the procedural site. It is intended for open and endoscopic procedures. The system is compromised of a pump, foot pedal, and power cord. The connection of the pumping unit to the foot pedal and fluid supply provides the user with a system capable of producing a broad range of pressures. This is based on a variable motor RPM. The motor is controlled by the use of a potentiometer and control dial. An electrically activated foot pedal controls the, running or stopping of the pump motor. The footswitch provide continuous flow when pressed.
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K Number
K063700Device Name
SPYGLASS IRRIGATION SYSTEM
Manufacturer
MEDICAL SCIENTIFIC, INC.
Date Cleared
2007-02-08
(57 days)
Product Code
LJH, KOG
Regulation Number
876.5130Why did this record match?
Product Code :
LJH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To provide irrigation during endoscopic surgical procedures
Device Description
Spyglass is an irrigation system for Endoscopy. This system is a peristaltic pump for delivering sterile water or saline through an endoscope (or catheter) for rinsing substances such as blood or bile from the procedural site. It is intended for open and endoscopic procedures.
The system is compromised of a pump, foot pedal, and a sterile single use disposable tubing set. The connection of the pumping unit to the foot pedal and fluid supply provides the user with a system capable of producing a broad range of pressures. The pump provides an adjustable flow-rate from 0 - 45 ml/min at 45 psi. This is based on a variable motor RPM. The motor is controlled by the use of a potentiometer and control dial. An electrically activated foot pedal controls the, running or stopping of the pump motor. The footswitch provide continuous flow when pressed. The tubing set will mate with a standard bottle of sterile water or saline and is provided sterile. A portion of the tubing set is placed in the peristaltic pump for flow creation.
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K Number
K062551Device Name
NEXUS IRRIGATION TUBING SET
Manufacturer
NEXUS MEDICAL, LLC
Date Cleared
2006-12-15
(107 days)
Product Code
LJH
Regulation Number
876.5130Why did this record match?
Product Code :
LJH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nexus Irrigation Tubing Set is intended for delivery of irrigating solutions from a container to an irrigation site during bladder irrigation, or endoscopic procedures such as cystoscopy, transurethral resection (TUR) and arthroscopic procedures.
Device Description
Not Found
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K Number
K042457Device Name
URO PRO
Manufacturer
W.O.M. WORLD OF MEDICINE AG
Date Cleared
2004-10-25
(45 days)
Product Code
LJH
Regulation Number
876.5130Why did this record match?
Product Code :
LJH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The URO Pro is an irrigation roller pump intended for the infusion of sterile solutions into the ureter and upper urinary tract during diagnostic and/or therapeutic endoscopic urologic procedures. It is indicated for the infusion of sterile solutions through an endoscope into the urogenital tract to irrigate the ureter and upper urinary tract in a controlled manner and to improve visibility of the surgical field during urologic procedures.
Device Description
The URO Pro is a microprocessor controlled pump which functions according to the peristaltic principle and incorporates the following major components and features: a power supply, a main cable, a roller wheel, a pump head, various setting keys and display elements. The pump head is designed with two pressure sensors to perform redundant pressure measurement. A software controlled active sensor monitoring ensures the conformity of the preset nominal pressure value with the actual measured pressure. In addition, the URO Pro is designed with several alarms to inform the operator in case of an overpressure.
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K Number
K040094Device Name
PIGGYBACK IRRIGATING SYSTEM
Manufacturer
KOSIN TECHNOLOGIES, LLC
Date Cleared
2004-04-15
(90 days)
Product Code
LJH
Regulation Number
876.5130Why did this record match?
Product Code :
LJH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for use in the irrigation of the ureter and renal pelvis during therapeutic and diagnostic ureteroscopy and/or endoscopic procedures.
Device Description
The I.V. Piggyback Irrigating System is designed with a releasably mounted modular endoscope valve assembly. It is designed for controlled irrigation through an endoscope during urological and/or endoscopic procedures. The design of the valve allows the irrigation to be controlled between the finger and the thumb of the hand holding the endoscope, leaving the other hand completely froe for stone extraction, lithotripsy, or biopsy.
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K Number
K023808Device Name
IRRIGATION SETS
Manufacturer
INTERNATIONAL MEDSURG CONNECTION
Date Cleared
2003-03-10
(116 days)
Product Code
LJH
Regulation Number
876.5130Why did this record match?
Product Code :
LJH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for delivery of irrigation solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cyctoscopy, transurethral resection (TUR) and arthroscopic procedures. This tubing segment is connected to the endoscope for delivery of solution to the irrigation site such as the bladder or knee.
Device Description
The International Medsurg Connections Irrigation Sets.
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K Number
K010607Device Name
MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001
Manufacturer
BENLAN, INC.
Date Cleared
2001-11-28
(272 days)
Product Code
LJH
Regulation Number
876.5130Why did this record match?
Product Code :
LJH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K010122Device Name
CONTINUOUS FLOW Y-TUBING
Manufacturer
G.U.-TEK
Date Cleared
2001-06-04
(139 days)
Product Code
LJH
Regulation Number
876.5130Why did this record match?
Product Code :
LJH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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