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serfas serfas generator serfas console serfas probe serfas handpiece cable serfas footswitch
Stryker Endoscopy
Summary: The Serfas Generator by Stryker Endoscopy is an ablation device used for tumor removal. It is typically used by surgeons in oncology and interventional radiology settings.
FDA Clearance Information
Pathway
510K
Number
K991960 ↗
Decision Date
August 13, 1999
Product Code
GEI
Device Class
Class 2
Evidence
0 studies
The Serfas Generator was cleared through the FDA 510(k) pathway on August 13, 1999. Manufactured by Stryker Endoscopy, it is classified as a Class II medical device.
What It Is
The Serfas Generator is an electrosurgical device designed for tissue ablation, particularly in tumor removal procedures. It operates by delivering controlled electrical energy to target tissues, causing them to heat and ablate. This device is part of a system that includes a console, probe, handpiece, cable, and footswitch, allowing for precise control during surgical procedures.
Clinical Applications
The Serfas Generator is commonly used in surgical oncology and interventional radiology for the ablation of tumors. It is suitable for use in both hospital and outpatient surgical settings. The device is often employed in procedures involving difficult-to-reach tumors where traditional surgical methods may be less effective or more invasive.
Indications for Use
The FDA-cleared indications for the Serfas Generator include its use in the ablation of tumors. This means it is intended for patients with tumors that require precise removal or reduction, often in cases where minimally invasive techniques are preferred.
Practical Considerations
The Serfas Generator system components, such as the probe and handpiece, are designed to be compatible with standard operating room equipment. Clinicians should ensure proper connection and calibration of the device before use. Familiarity with the footswitch operation is essential for effective control during procedures.
Frequently Asked Questions
What is the Serfas Generator used for?
The Serfas Generator is used for the ablation of tumors, providing a minimally invasive option for tissue removal.
What specialties typically use this device?
The Serfas Generator is typically used by surgical oncologists and interventional radiologists.
What are the FDA-cleared indications?
The device is cleared for the ablation of tumors, making it suitable for patients requiring precise tissue removal.
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.