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serfas energy system
Stryker Endoscopy
Summary: The Serfas Energy System is an ablation device used for tumor treatment. It is primarily used by surgeons and interventional radiologists in oncology settings.
FDA Clearance Information
Pathway
510K
Number
K041810 ↗
Decision Date
December 21, 2004
Product Code
GEI
Device Class
Class 2
Evidence
0 studies
The Serfas Energy System by Stryker Endoscopy was cleared via the FDA 510k pathway on December 21, 2004. It is a Class 2 medical device under product code GEI.
What It Is
The Serfas Energy System is an advanced ablation device designed to treat tumors through energy-based techniques. It operates by delivering controlled energy to target tissues, causing thermal destruction of tumor cells. This device is typically used in minimally invasive procedures, offering precision and reduced recovery times compared to traditional surgical methods.
Clinical Applications
Commonly used in oncology, the Serfas Energy System is employed in procedures such as liver, kidney, and lung tumor ablations. It is suitable for use in both hospital and outpatient settings, primarily by surgical oncologists and interventional radiologists. The device is beneficial for patients who are not candidates for traditional surgery due to the location or size of the tumor.
Indications for Use
The FDA-cleared indications for the Serfas Energy System include the ablation of soft tissue tumors. It is intended for patients with tumors that can be targeted and treated with energy-based methods, providing an alternative to surgical resection.
Practical Considerations
The Serfas Energy System is available in various sizes to accommodate different tumor sizes and locations. It is compatible with standard imaging guidance systems, which aids in precise targeting. Clinicians should be trained in energy-based ablation techniques to maximize the device's effectiveness.
Frequently Asked Questions
What is the Serfas Energy System used for?
The Serfas Energy System is used for the ablation of soft tissue tumors, providing a minimally invasive treatment option.
What specialties typically use this device?
This device is typically used by surgical oncologists and interventional radiologists.
What are the FDA-cleared indications?
The device is indicated for the ablation of soft tissue tumors, offering an alternative to traditional surgical methods.
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.