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sira rfa electrosurgical device
Innoblative Designs
Summary: The SIRA RFA Electrosurgical Device is used for tissue ablation, primarily in breast conserving surgeries. It is utilized by surgical oncologists and is FDA-cleared for tumor ablation.
FDA Clearance Information
Pathway
510K
Number
K181071 ↗
Decision Date
January 16, 2019
Product Code
GEI
Device Class
Class 2
Evidence
0 studies
The SIRA RFA Electrosurgical Device was cleared via the FDA 510k pathway on January 16, 2019. Manufactured by Innoblative Designs, it is classified as a Class 2 device under product code GEI.
What It Is
The SIRA RFA Electrosurgical Device is a radiofrequency ablation tool designed for surgical procedures, particularly in oncology. It delivers controlled thermal energy to ablate tissue, making it useful in removing or reducing tumor masses. The device is designed to be used adjunctively during surgeries, providing precise ablation to complement traditional surgical techniques.
Clinical Applications
This device is commonly used in breast conserving surgeries, where precise ablation of tumor margins is critical. It is typically employed by surgical oncologists in hospital operating rooms. The device is suitable for patients undergoing procedures where tumor reduction is necessary, particularly in breast cancer cases.
Indications for Use
The FDA indications suggest that the device is intended for use in surgical procedures requiring tissue ablation. It is particularly indicated for patients with tumors where ablation can assist in surgical outcomes.
Practical Considerations
The device is designed to be compatible with standard surgical equipment and techniques. Clinicians should be trained in radiofrequency ablation procedures to optimize outcomes. Consideration should be given to the size and location of the tumor when planning the use of this device.
Related Literature
The linked study investigated the feasibility of using the SIRA RFA Electrosurgical Device as an adjunct in breast conserving surgery. While specific findings and limitations are not detailed, the study likely focused on the device's safety and efficacy in achieving clear surgical margins. Further research would be necessary to establish comprehensive clinical guidelines.
Frequently Asked Questions
What is the SIRA RFA Electrosurgical Device used for?
It is used for tissue ablation during surgical procedures, particularly in breast conserving surgeries.
What specialties typically use this device?
Surgical oncologists, especially those performing breast cancer surgeries, typically use this device.
What are the FDA-cleared indications?
The device is indicated for tissue ablation in surgical procedures, particularly for tumor reduction in oncology settings.
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.