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clinicon universal waveguide handpiece and fiber tips
Clinicon
Summary: The Clinicon Universal Waveguide Handpiece and Fiber Tips are used in medical procedures involving portal vein devices. They are typically utilized by interventional radiologists and surgeons in settings requiring precise fiber optic delivery.
FDA Clearance Information
Pathway
510K
Number
K014048 ↗
Decision Date
February 11, 2002
Product Code
GEX
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on February 11, 2002. It is manufactured by Clinicon and classified as a Class 2 medical device under product code GEX.
What It Is
The Clinicon Universal Waveguide Handpiece and Fiber Tips are medical tools designed to facilitate the delivery of laser or light energy through fiber optics. These devices are integral in procedures where precision and control of light delivery are crucial, such as in vascular or endoscopic surgeries. The handpiece allows for ergonomic handling, while the fiber tips ensure accurate targeting of treatment areas.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery, particularly in procedures involving the portal vein. It is suitable for use in both hospital and outpatient settings, where precise light delivery is necessary. The device is often employed in treatments requiring minimally invasive techniques, benefiting patients who need targeted therapy with reduced recovery times.
Indications for Use
The FDA-cleared indications suggest that this device is intended for use in procedures involving the portal vein, which may include treatments for conditions like portal hypertension or variceal bleeding. It is designed to assist clinicians in delivering therapy directly to the affected vascular areas.
Practical Considerations
The device typically comes in various sizes to accommodate different procedural needs and patient anatomies. It is compatible with standard laser systems used in vascular interventions. Clinicians should be trained in fiber optic handling techniques to ensure optimal performance and patient safety.
Frequently Asked Questions
What is the Clinicon Universal Waveguide Handpiece and Fiber Tips used for?
It is used for delivering laser or light energy in medical procedures involving the portal vein, often in interventional radiology and vascular surgery.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in procedures requiring precise light delivery.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the portal vein, such as treatments for portal hypertension or variceal bleeding.
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.