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laborie fiberoptic pressure sensor interface
Tridak Division Of Indicon
Summary: The Laborie Fiberoptic Pressure Sensor Interface is a medical device used to measure pressure in various clinical settings. It is commonly used by urologists and gastroenterologists for diagnostic procedures.
FDA Clearance Information
Pathway
510K
Number
K853059 ↗
Decision Date
January 10, 1986
Product Code
FAP
Device Class
Class 2
Evidence
0 studies
The Laborie Fiberoptic Pressure Sensor Interface was cleared by the FDA through the 510(k) pathway on January 10, 1986. It is manufactured by Tridak Division Of Indicon and is classified as a Class II device.
What It Is
The Laborie Fiberoptic Pressure Sensor Interface is a device that utilizes fiberoptic technology to measure pressure within the body. It is designed to provide accurate pressure readings, which are crucial for diagnosing and monitoring various medical conditions. The device interfaces with other diagnostic equipment to relay pressure data, aiding clinicians in making informed decisions.
Clinical Applications
This device is commonly used in urodynamic studies to assess bladder function and in gastrointestinal motility studies to evaluate esophageal and anorectal pressures. It is typically employed in hospital settings, specialized clinics, and diagnostic laboratories. The primary users include urologists, gastroenterologists, and other specialists involved in diagnosing functional disorders of the urinary and gastrointestinal systems.
Indications for Use
The FDA indications suggest that this device is intended for use in measuring internal body pressures, which is essential for diagnosing conditions like urinary incontinence, bladder dysfunction, and gastrointestinal motility disorders. It is suitable for patients experiencing symptoms related to these conditions.
Practical Considerations
When using the Laborie Fiberoptic Pressure Sensor Interface, clinicians should ensure compatibility with existing diagnostic equipment. The device is available in various sizes to accommodate different anatomical requirements. Proper technique and calibration are essential for obtaining accurate pressure readings.
Frequently Asked Questions
What is the Laborie Fiberoptic Pressure Sensor Interface used for?
It is used for measuring internal body pressures, particularly in urodynamic and gastrointestinal motility studies.
What specialties typically use this device?
Urologists and gastroenterologists commonly use this device for diagnostic purposes.
What are the FDA-cleared indications?
The device is indicated for measuring internal pressures to aid in diagnosing conditions like urinary incontinence and gastrointestinal motility disorders.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.