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510(k) Data Aggregation
K Number
K212830Device Name
CT3000Pro
Manufacturer
SRS Medical
Date Cleared
2021-12-21
(105 days)
Product Code
FEN, EXQ
Regulation Number
876.1620Why did this record match?
Product Code :
FEN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CT3000Pro is intended for urodynamic testing. The equipment performs standard tests including uroflowmeter, cystometry, micturition, electromyography and urethral pressure profiles. The non-invasive option utilizes a penile cuff (UroCuff-Classic or UroCuff-DC) for non-invasive testing of bladder activity, by assessing the pressure necessary to interrupt urine flow.
The CT3000Pro is intended for use under the direction of a licensed physician or health care professional in an office or hospital setting.
Device Description
The CT3000Pro system is an urodynamics testing system which combines an all-in-one touchscreen PC with the CT3000Pro console. Patient information and all data from the tests are stored on the PC's hard disk and the printer enables the user to print a hard copy report of the recorded data. It features a scale to record urine flow, as well as a pump for cystometrogram and urethral pressure profile studies.
The CT3000Pro PC software runs three types of tests: (a) catheterized urodynamics, (b) non- invasive urodynamics, and (c) uroflow studies.
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K Number
K082701Device Name
URONIRS, MODEL 2000
Manufacturer
URODYNAMIX TECHNOLOGIES LTD
Date Cleared
2008-12-18
(93 days)
Product Code
FEN
Regulation Number
876.1620Why did this record match?
Product Code :
FEN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The URONIRS 2000 device is intended to be used in conjunction with commercially available uroflowmeters and bladder ultrasound systems for noninvasive testing of bladder activity, aiding in the diagnosis of urinary incontinence and lower urinary tract symptoms. The device is used under the direction of a licensed physician or health care professional.
The URONIRS 2000 device is indicated for non-invasive testing of bladder activity in an office or hospital setting.
Device Description
The URONIRS 2000 is an active medical device indicated for non-invasive testing of bladder activity in an office or hospital setting.
The device consists of a medical grade Tablet PC running the URONIRS application software, a URONIRS base station for data acquisition, a custom designed cable with an optical sensor end and a single use, disposable patch.
The base station provides the laser output and accepts NIRS data input from the sensor via the sensor cable and charges the Tablet PC when plugged in. The base station communicates with the tablet PC via Bluetooth.
During bladder voiding, URONIRS 2000 measures concentration changes in oxygenated haemoglobin (HbO2), de-oxygenated haemoglobin (Hb) and cytochrome (Cyt) while a commercial uroflowmeter simultaneously measures uroflow data (flow and volume). The data is sent to the tablet PC via Bluetooth connection for display to the clinical users.
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K Number
K073552Device Name
LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY
Manufacturer
LABORIE MEDICAL TECHNOLOGIES, CORP
Date Cleared
2008-03-05
(78 days)
Product Code
FEN
Regulation Number
876.1620Why did this record match?
Product Code :
FEN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Laborie Urodynamic systems are intended for Urodynamics testing. The traditional equipment performs standard tests including uroflowmeter, cystometry, micturition, electromyography and urethral pressure profiles. The accessory to our standard equipment, Tetra, uses near infrared spectroscopy, for non-invasive testing of bladder activity, aiding in the diagnosis of patients with lower urinary tract symptoms - that is patients who suffer from Urinary Incontinence.
All Urodynamic equipment including the Laborie Urodynamic System with Tetra Accessory are for use under the direction of a licensed physical or health care professional in an office or hospital setting.
Device Description
The complete device includes traditional Urodynamic system and the Tetra accessory. That is all the standard components, for uroflowmetry and pressure measurement, and the new non-invasive component the Tetra accessory to detect bladder activity.
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K Number
K001386Device Name
ACCUSET SENSOR, MODEL 2000
Manufacturer
PELVICARE, INC.
Date Cleared
2000-07-17
(76 days)
Product Code
FEN
Regulation Number
876.1620Why did this record match?
Product Code :
FEN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992715Device Name
NEURO URODYNAMIC SUITE, MODEL 9032E0101
Manufacturer
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
Date Cleared
2000-02-28
(200 days)
Product Code
FEN, GWF, JXE
Regulation Number
876.1620Why did this record match?
Product Code :
FEN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Neuro-Urodynamics Suite for Duet / Duet MultiP is indicated for electrophysiological testing of the pelvic organs including motor nerve conduction, sacral reflex, and free-run EMG tests.
Device Description
The Duet version 8.1 is enhanced with a new suite of test programs for EMG and Motor Nerve conduction measurements. The suite is called Neuro Urodynamics Suite and consists of the following predefined testprogram:
- Neuro Free Run EMG
- Neuro Motor Nerve Conduction
- Neuro Sacral Reflex
The Neuro Urodynamic Suite is together with Duet MultiP intended to record a patients urodynamic functions and examination of the motor innervation of the spincters and the pelvic floor and the sensory innervation of pelvic structures.
The whole system includes transducers, devices, tubing, catheters and electrodes. The tests are operated just like the urodynamic and anorectal tests. A license number is required to enable the software for the Neuro Urodynamic Suite.
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K Number
K983325Device Name
IN-PROBE II URODYNAMIC SYSTEM
Manufacturer
INFLUENCE, INC.
Date Cleared
1998-11-24
(63 days)
Product Code
FEN
Regulation Number
876.1620Why did this record match?
Product Code :
FEN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The In-Probe II Urodynamic System is indicated as an aid in the diagnosis of voiding dysfunction in males and females. In females, the In-Probe II Urodynamic System is also indicated for measuring urethral angle during straining.
Device Description
The In-Probe II Urodynamic System is a compact and portable urodynamic system capable of performing cystometrography (CMG) for both men and women. In addition, for women, the device can provide objective measurement of the changes in urethral angle that occur during patient straining.
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K Number
K970595Device Name
CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP
Manufacturer
CIRCON VIDEO
Date Cleared
1997-10-24
(248 days)
Product Code
FEN
Regulation Number
876.1620Why did this record match?
Product Code :
FEN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Circon Endotek OM-4 Urodynamics Monitoring System is indicated for urodynamic diagnostic procedures only. It is to be operated only be qualified physicians or qualified personnel under the direction and supervision of a physician trained in urodynamic monitoring techniques.
The Circon Endotek OM-4 H2O Cystometry Pump is used to pressurize the filling media during water cystometry diagnostic procedures. The device is designed to be used with the Circon Endotek OM-4 Urodynamic Monitoring System.
Device Description
The Circon Endotek OM-4 H2O Cystometry Pump is a peristallic pump used with the The Olicon Endotek OM-4 Urodynamic Monitoring System for pressurizing the filling media during cystometry measurements.
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K Number
K971911Device Name
LUMAX CYSTOMETRY ADMINISTRATION TUBE SET
Manufacturer
MEDAMICUS, INC.
Date Cleared
1997-06-03
(36 days)
Product Code
FEN
Regulation Number
876.1620Why did this record match?
Product Code :
FEN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LuMax Cystometry Tube Set is intended to be used in the exact same manner as the previous tube sets manufactured by NASP and cleared by FDA under K911865/B. The intended use of these tube sets is to provide a conduit from a liquid resevoir to the infusion lumen of a bladder pressure catheter.
The LuMax Cystometry Tube Set is to be used to provide a conduit from a liguid reservoir to the infusion lumen of a bladder catheter whenever filling a bladder is required in conjunction with performing a Urodynamic Cystometry test.
Device Description
The LuMax Cystometry Tube Set consists of a vented spike with a drip chamber for connection to the liquid reservoir, usually a one to three liter saline or DI water bag, a roller clamp for regulating fluid flow rates, and a male luer lock connector for connecting to the filling lumen of the bladder catheter. It is assembled with polyurethane tubing giving it an overall length of 72 inches.
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K Number
K964522Device Name
ELLIPSE 4
Manufacturer
ANDROMEDA MEDIZINISCHE SYSTEME GMBH
Date Cleared
1997-03-21
(129 days)
Product Code
FEN, PAN
Regulation Number
876.1620Why did this record match?
Product Code :
FEN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ellipse 4™ is intended to assist in the diagnosis of incontinence and/or voiding disorders.
The Ellipse 4™ is a Urodynamic System. It can perform the following tests: Flowmetry, Cystometry, Pressure Flow, Urethral Pressure Profile and EMG.
Device Description
The Ellipse 4™ is a small, compact device that can register pressures, uroflow and EMG from the patient. The signals are AD converted and displayed on a LCD screen, printed on a thermal printer and stored in memory. After the recording, the data can be copied on a printer or downloaded to a PC using a network.
The Ellipse 4™ uses microp catheters (MTC's) for recording the pressures, and surface electrodes.
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K Number
K960503Device Name
DANTEC DUET
Manufacturer
DANTEC MEDICAL, INC.
Date Cleared
1996-09-16
(227 days)
Product Code
FEN
Regulation Number
876.1620Why did this record match?
Product Code :
FEN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dantec Duet™ system is intended for urodynamics testing. The Duet™ system is intended to assist practitioners in executing specific urodynamics test protocols, collecting data during protocol execution, analyzing collected data, preparing written reports and archiving patient and testing information.
General indications for use include use in patients with lower urinary tract voiding or continence problems, and more specifically incontinent patients, patients with bladder outlet obstructions, patients with neurogenic bladder dysfunction and some children with complex voiding / incontinence problems.
Device Description
The Dantec Duet™ is a computerized urodynamics measurement system. The system consists of a mobile cart or "trolley" with the following components mounted on it: a 486 based computer, color monitor, printer, dedicated keyboard, digital and analog measurement electronics, Windows™ based application software, transducers for measuring EMG, pressure, flow and weight, infusion stand, puller with arm, CO₂ gas pump, water pump, patient interface module and patient connecting accessories.
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