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The injeTAK Adjustable Tip Needles are intended to be used to deliver a variety of legally marketed drugs into tissues or structures during cystoscopic procedures. They are provided sterile for single use only.

The injeTAK Adjustable Tip Needles (injeTAK Needles) are intended to be used to deliver a variety of legally marketed drugs into tissues of structures during cystoscopic procedures. They are provided sterile for single use only. The needles will contact the bladder tissue and urine fluid in the patient. The typical injection procedure lasts 10-20 minutes; each injection spot contact lasts approximately 5 seconds but may vary slightly depending on the skill of surgeon. The models of the injeTAK needles are used with a rigid or flexible cystoscope during cystoscopic procedures and differ in length of the needle dependent upon the type of procedure. The intended use does not vary based on the model number or difference in measurement specifications. The injeTAK Needle comprises of a needle cannula, contrast mark, needle sheath, handle, needle length dial, hub/luer connector, lock-pin, and a seal ring located inside the handle.

The Solar Compact is intended to record, store, view, and analyze pressure, impedance, and EMG data, gathered from anywhere in the gastrointestinal tract (pharynx, esophagus, stomach, and anorectal area, including rectum and pelvic floor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Designated catheters and accessories are required for measurement in each specific area of the gastrointestinal tract. An optional perfusion pump can also be used for automated balloon filling (for anorectal manometry studies). The filling lumen of the catheter can be connected to the perfusion pump. The Solar Compact is indicated for use in adult to infants with common gastrointestinal conditions, for the monitoring and diagnosis of motility disorders of the GI tract.

The Solar Compact is a medical device for measuring gastrointestinal motility characteristics. The system consists of an electromechanical hardware device which connects to pressure catheters (air-charged or solid-state), and a PC software. Catheters provide measurements of pressure and impedance to the device from various sites along the gastrointestinal tract, which are then displayed and analyzed by the Laborie PC software. This provides the clinician with data that may aid in the diagnosis or management of various gastrointestinal disorders. Additionally, the system connects to provide EMG measurements of the muscles along the pelvic floor. Devices such as pressure catheters and surface electrodes are required to complete a gastrointestinal motility investigation, but they are not considered part of the Solar Compact device and not included standard with the system. The device hardware consists of an external housing, pneumatics to inflate and deflate rectal balloons, and electronics to readout data from the pressure catheters and to control all other functions of the system. The device connects to a PC via Bluetooth to display measurements within the Laborie software. The Laborie software contains a patient database module, and an analysis module. The software displays measurements from the system as time-tracing based plots, Clouse Countour Plots (High Resolution Manometry), and as 3D plots. Clinicians can analyze the data provided by placing markers and using calculations within the software. The device does not provide an independent diagnosis. The Solar Compact device is compatible with a number of of catheters for these aforementioned parameter measurements. For a full list of these compatible catheters please consult the instructions for use.

The Solar anorectal manometry catheter is a non-sterile, single patient use catheter for use on patient requiring anorectal manometry testing.

The Solar™ Anorectal Manometry Catheter is a high-resolution anorectal manometry (HRAM) catheter. It is a diagnostic device used to assess the function of anal and rectum muscles. The device consists of 10 air-charged sensing balloons which can sense pressures during anorectal manometry, along with a distal balloon used for the assessment of recto anal inhibitory reflex (RAIR). The catheter is disposable and non-sterile. Through manual insertion in the device assesses pressures within the anorectal anatomy as well as assessing sensation and reflexes. This product is non-sterile, single patient use catheter intended for use with a reusable Solar™ Anometry Charger on patients requiring lower gastrointestinal pressure measurements.

The injeTak™ Adjustable Tip Needles are intended to be used to deliver a variety of legally marketed drugs into tissues or structures during cystoscopic procedures. They are provided sterile and single use only.

The injeTAK'" Adjustable Tip Needle consists of a metal needle cannula and an outer movable sheath with an attached adjusting mechanism. The needle sheath diameter is 6Fr with 35-50cm in length, The stainless steel needle is 25gauge Needle tip length adjusting mechanism is used to adjust & set the relative distance between the distal needle point to the distal end tip of needle sheath in a range of 0-5 millimeter (mm). Numbers (0, 2, 3, 5) printed on handle of the adjusting mechanism are used to indicate the individual needle tip (penetration) lengths in millimeter (mm) unit.

The EVOX Electro Diagnostic Device is intended for the testing of sacral reflexes, pudendal nerve terminal motor latency (PNTML) studies. electromyography (EMG), and cerebral pudendal somatosensory evoked potential (SEP).

The EVOX Electro-Diagnostic Device utilizes Laborie Urodynamic equipment 510(k) exempt under section § 876.1620 or with another microprocessor that is compatible with the required capability. The Laborie EVOX Electro Diagnostic Device will help diagnose and perform evaluation tests for urinary and fecal incontinence as well as other neurological and physiological assessment, including: Pudendal Nerve Terminal Motor Latency with St Marks Electrodes Anal Sphincter CN EMG Cerebral Pudendal Somatosensory Evoked Potential Sacral Reflexes Calculations will include: latency, peak, duration, conduction velocity and area. The equipment includes the Evox Electro-diagnostic Software and the hardware required to perform the stated tests which include: - Laborie 94-based Hardware with Integrated Electrodiagnostic Stimulation . - . Ring/Bar Stimulation Electrodes - Needle/Cup/Patch EMG/ECG Electrodes . - St. Mark's Electrode and Cable . - EMG/ECG Cabling .

The NuWav Ultrasound Probe System is intended to used to perform diagnostic general ultrasound studies including Fetal, Abdominal (Solid Organs, Aneurysms, bladder), Pediatric, Small organ (breast, thyroid, bladder, testes, prostate), Neonatal Cephalic, Cardiac, Trans-vaginal, Trans-rectal, Peripheral Vascular, and Musculoskeletal (Conventional and Superficial). The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles or other anatomical structures as well as performing Urodynamic Studies.

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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.

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.

The UROSTYM ™ Biofeedback and Stimulation Device is used for treating urinary incontinence by way of perineal re-education.. The Urostym probes are non-implanted electrical devices applied to the pelvic floor musculature and surrounding structures for therapy in the treatment of urinary incontinence. The probes and patches are provided nonsterile for single (individual) patient use / disposable. The probes are for office or hospital use under the direction of a physician or other licensed healthcare professional.

UROSTYM™ Biofeedback and Stimulation Device and Accessories

The Laborie UROSTYM™ is intended to be used in treating urinary incontinence (stress incontinence (hypermobility) and bladder instability) by way of perineal reeducation. Using the available accessories, the system can be used for performing biofeedback and electro-stimulation therapy as treatment modalities for urinary incontinence.

UROSTYM™ Biofeedback and Stimulation Device