đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Intended to measure internal body pressures during diagnostic testing.
- Intended to interface with compatible pressure-measurement and recording equipment.
- Intended for use in clinical evaluation of pressure-related functional disorders when used according to the manufacturer’s labeling.
Clinical Applications
- Measuring bladder and urinary tract pressures during urodynamic testing.
- Measuring esophageal pressures during gastrointestinal motility evaluation.
- Measuring anorectal pressures during anorectal manometry.
- Relaying pressure data to compatible diagnostic recording equipment.
Practical Considerations
- Confirm compatibility with the pressure-monitoring system, connectors, recording equipment, and software before use.
- The sensor and interface should be calibrated and zeroed according to the manufacturer’s instructions to support accurate readings.
- Use the appropriate sensor configuration and size for the intended anatomic site and diagnostic study.
- The available FDA record does not establish that the device is MRI safe; verify the manufacturer’s MRI labeling before bringing any component into an MRI environment.
- Follow applicable cleaning, reprocessing, and handling instructions; contraindications and limitations should be checked in the current manufacturer’s labeling.
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.