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ellusa generator ellusa bayonet tip ellusa rf-cobb tip ellusa sp-pack and tips ellusa tip set
Ellu
Summary: The Ellusa Generator and Tips are used for portal vein procedures, providing precision in complex surgical settings. Typically utilized by surgeons specializing in vascular and tumor removal surgeries.
FDA Clearance Information
Pathway 510K
Number K202562 ↗
Decision Date November 2, 2020
Product Code GEI
Device Class Class 2
Evidence 0 studies
The Ellusa Generator and Tips were cleared through the FDA 510(k) pathway on November 2, 2020, by Ellu. It is a Class 2 medical device under product code GEI.
What It Is
The Ellusa Generator and its associated tips, including the bayonet and RF-Cobb tips, are specialized surgical tools designed for precision in portal vein procedures. These devices utilize radiofrequency energy to assist in the dissection and removal of tissue while preserving surrounding vascular structures. The system is designed to operate in deep and narrow surgical fields, providing enhanced control and accuracy.
Clinical Applications
The Ellusa device is commonly used in surgical procedures involving the portal vein, particularly in complex cases requiring precise dissection. It is frequently employed in neurosurgery and vascular surgery settings, often for tumor removal or vascular preservation procedures. The device is suitable for use in both hospital operating rooms and specialized surgical centers, catering to adult and pediatric patient populations.
Indications for Use
The FDA-cleared indications for the Ellusa device focus on its use in procedures involving the portal vein, particularly where precision and preservation of surrounding vascular structures are critical. It is ideal for patients requiring complex surgical interventions in narrow or deep anatomical spaces.
Practical Considerations
The Ellusa system is compatible with various surgical setups and requires standard power sources. Surgeons should be familiar with radiofrequency surgical techniques and consider the specific anatomical challenges of each patient when selecting the appropriate tip. Proper training in the use of the device is recommended to maximize its benefits.
Related Literature
The linked study investigated the use of a pulsed laser-induced liquid jet system for tumor removal at the skull base, emphasizing vascular preservation through a transsphenoidal approach. The study found that the system allowed for effective tumor dissection while maintaining the integrity of fine blood vessels in challenging surgical environments. However, the study was limited by its focus on a specific surgical approach and patient population, highlighting the need for further research in diverse clinical settings.
Frequently Asked Questions
What is Ellusa Generator and Tips used for?
The Ellusa system is used for precision surgical procedures involving the portal vein, particularly in complex cases requiring tissue dissection and vascular preservation.
What specialties typically use this device?
The device is commonly used by neurosurgeons and vascular surgeons, particularly those involved in tumor removal and complex vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in portal vein procedures where precision and preservation of surrounding vascular structures are 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.