đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- The FDA record identifies the Ellusa Generator and tips as a Class II electrosurgical device cleared through the 510(k) pathway under product code GEI.
- The supplied FDA indication information is limited to “Summary”; a specific FDA-cleared anatomical indication or procedure is not available in the provided record.
Clinical Applications
- Use of the generator with compatible Ellusa tips during surgical tissue dissection.
- Use of the bayonet tip, RF-Cobb tip, SP-Pack and tip sets when selected for the applicable surgical field and tissue-handling task.
- Use in operating-room procedures where radiofrequency electrosurgical energy is appropriate and the device labeling permits its use.
Practical Considerations
- Use only compatible Ellusa tips and accessories according to the current manufacturer instructions for use.
- The surgeon should select the tip based on the operative anatomy, access angle, tissue target and required degree of dissection control.
- Radiofrequency energy can cause thermal injury, bleeding, smoke and unintended damage to adjacent tissue; standard electrosurgical precautions are required.
- Confirm generator compatibility, cables, power settings and grounding or return-electrode requirements before use.
- MRI safety status, sterilization requirements, reuse status, tip dimensions and service life should be verified in the current manufacturer labeling; they cannot be determined from the supplied FDA summary.
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.