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stryker 90-s max serfas energy probe
Stryker
Summary: The Stryker 90-S Max Serfas Energy Probe is a medical device used for tumor ablation. It is typically utilized by surgeons and interventional radiologists in oncology settings.
FDA Clearance Information
Pathway
510K
Number
K171391 ↗
Decision Date
January 26, 2018
Product Code
GEI
Device Class
Class 2
Evidence
0 studies
The Stryker 90-S Max Serfas Energy Probe was cleared via the FDA 510k pathway on January 26, 2018. It is manufactured by Stryker and classified as a Class 2 device.
What It Is
The Stryker 90-S Max Serfas Energy Probe is an advanced ablation device designed for precise tumor removal. It uses energy to ablate or destroy tumor tissue, offering a minimally invasive option for patients. The device is engineered to provide controlled energy delivery, ensuring effective treatment while minimizing damage to surrounding healthy tissues.
Clinical Applications
This device is commonly used in oncology for the ablation of tumors, particularly in liver, kidney, and lung cancers. It is typically employed in surgical or interventional radiology settings, where precise tissue ablation is required. The device is suitable for adult patients with tumors that are accessible for percutaneous or open surgical approaches.
Indications for Use
The FDA indications for the Stryker 90-S Max Serfas Energy Probe include the ablation of soft tissue tumors. It is intended for patients with tumors that are difficult to remove surgically or for those who require a minimally invasive treatment option.
Practical Considerations
The device is available in various sizes to accommodate different procedural needs and patient anatomies. It is compatible with standard ablation generators and requires careful handling to ensure precise energy delivery. Clinicians should be trained in its use to maximize efficacy and safety.
Frequently Asked Questions
What is the Stryker 90-S Max Serfas Energy Probe used for?
It is used for the ablation of soft tissue tumors, providing a minimally invasive treatment option.
What specialties typically use this device?
Oncology, interventional radiology, and surgical specialties commonly use this device for tumor ablation.
What are the FDA-cleared indications?
The device is indicated for the ablation of soft tissue tumors, offering a treatment option for patients with difficult-to-remove tumors.
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.