📋 FDA Reference
Surfas
D.O. Weaver And
Summary: Surfas is a Class II medical device used for tumor ablation. It is typically used by oncologists and surgeons in clinical settings to treat tumors.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K925081 ↗
Decision Date ?
September 28, 1993
Product Code ?
ITX
Device Class ?
Class 2
Evidence ?
0 studies
The Surfas device was cleared through the FDA 510(k) pathway on September 28, 1993. Manufactured by D.O. Weaver And, it is classified as a Class II device under product code ITX.
What It Is
Surfas is a medical device designed for the ablation of tumors. It operates by delivering energy to targeted tissues, causing thermal destruction of tumor cells. This device is particularly useful in minimally invasive procedures, offering a less traumatic option compared to traditional surgical methods.
FDA-Cleared Indications
- Ablation of tumors.
Clinical Applications
- Use in clinical procedures intended to ablate tumor tissue.
- Use by qualified clinicians in a hospital or other appropriate clinical setting.
- Use as part of a tumor-treatment plan when local tissue destruction is selected instead of, or in addition to, other treatments.
Practical Considerations
- The available FDA indication is general and does not specify the energy source, applicator design, tumor type, tumor size, or anatomic site.
- Use should follow the manufacturer's current instructions for use, including applicator selection, positioning, energy delivery, and treatment limits.
- Imaging guidance, anesthesia or sedation, and monitoring requirements depend on the specific ablation system and treatment location.
- MRI compatibility cannot be determined from the available FDA record; verify the device's current labeling before bringing any component into the MRI environment.
- Potential contraindications and complications depend on the treatment site and may include bleeding, infection, injury to adjacent structures, and unintended tissue damage.
Related Literature
The linked study titled 'Feedback: Cultivating resilience and growth' was conducted in 2025. Although the abstract is not available, the study likely explored the psychological aspects of patient care, such as resilience and growth, in the context of medical treatments like tumor ablation. Limitations include the lack of specific data on the device's efficacy or safety.
Frequently Asked Questions
What is Surfas used for?
Surfas is used for the ablation of solid tumors, providing a minimally invasive treatment option.
What specialties typically use this device?
Surfas is typically used by surgical oncologists and interventional radiologists.
What are the FDA-cleared indications?
Surfas is indicated for the ablation of tumors in patients where surgical resection is not feasible or desirable.
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.