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endolumina ii transillumination system 56fr e-5630 50fr e-5030 and 40fr e-4020 endolumina ii detachable tips 56fr ta
Bioenterics
Summary: The Endolumina II Transillumination System by Bioenterics is a medical device used for portal vein procedures. It is typically used by interventional radiologists and surgeons.
FDA Clearance Information
Pathway
510K
Number
K964561 ↗
Decision Date
February 11, 1997
Product Code
FDG
Device Class
Class 1
Evidence
0 studies
The Endolumina II Transillumination System was cleared through the FDA's 510(k) pathway on February 11, 1997. Manufactured by Bioenterics, it is classified as a Class 1 device under product code FDG.
What It Is
The Endolumina II Transillumination System is a device designed to assist in portal vein procedures by providing illumination and visualization. It consists of detachable tips that can be used for different sizes of procedures (56Fr, 50Fr, and 40Fr). This system enhances the clinician's ability to navigate and visualize the portal vein, which is crucial for precise interventions.
Clinical Applications
This device is commonly used in interventional radiology and surgical settings, particularly for procedures involving the portal vein. It is beneficial in complex cases where enhanced visualization is required, such as in patients with liver disease or portal hypertension. The system is suitable for use in hospitals and specialized clinics where advanced vascular procedures are performed.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures involving the portal vein. It is particularly useful for patients requiring enhanced visualization during interventions, such as those with liver conditions or vascular abnormalities.
Practical Considerations
The device comes with detachable tips in various sizes (56Fr, 50Fr, and 40Fr), allowing for flexibility depending on the procedure's requirements. Clinicians should ensure compatibility with existing equipment and be familiar with the transillumination technique to maximize the device's effectiveness.
Frequently Asked Questions
What is the Endolumina II Transillumination System used for?
It is used for enhancing visualization during portal vein procedures, aiding in precise interventions.
What specialties typically use this device?
Interventional radiologists and surgeons specializing in vascular and liver procedures commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the portal vein, particularly where enhanced visualization is necessary.
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.