đź“‹ FDA Reference
Scb Valleylab Force Fx Interface Unit
Karl Storz Endoscopy-America
Summary: The scb Valleylab Force FX Interface Unit is a medical device used for tumor ablation procedures. It is primarily utilized by surgeons and oncologists in settings such as hospitals and surgical centers.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K041912 ↗
Decision Date ?
October 25, 2004
Product Code ?
ODA
Device Class ?
Class 2
Evidence ?
0 studies
The scb Valleylab Force FX Interface Unit was cleared by the FDA through the 510k pathway on October 25, 2004. It is manufactured by Karl Storz Endoscopy-America and classified as a Class 2 device.
What It Is
The scb Valleylab Force FX Interface Unit is an interface device designed to integrate with electrosurgical generators for tumor ablation. It facilitates precise control and delivery of electrical energy to target tissues, allowing for effective ablation of tumors. This device is part of a system that enhances the safety and efficacy of electrosurgical procedures.
FDA-Cleared Indications
- Use as an interface component with compatible electrosurgical equipment according to the cleared system labeling.
- The FDA summary available for 510(k) K041912 does not specify a standalone indication for treating tumors.
Clinical Applications
- Connecting or interfacing compatible electrosurgical equipment during procedures.
- Supporting operation of an electrosurgical system when used according to the manufacturer’s instructions.
- Use in hospital or surgical-center settings as part of a compatible electrosurgical setup.
Practical Considerations
- Confirm compatibility with the specific electrosurgical generator, cables, accessories, and other system components before use.
- This interface unit should not be treated as a standalone tumor-ablation device unless the complete system labeling specifically supports that use.
- Follow the manufacturer’s instructions for installation, configuration, inspection, cleaning, and electrical safety checks.
- The available FDA record does not establish MRI safety; do not bring the device into an MRI environment unless its labeling specifically permits it.
- Use only by trained personnel familiar with electrosurgical equipment and the risks of unintended burns, electrical injury, interference, or equipment malfunction.
Frequently Asked Questions
What is scb Valleylab Force FX Interface Unit used for?
It is used for tumor ablation procedures, providing precise control of electrical energy delivery during surgery.
What specialties typically use this device?
Surgeons and interventional radiologists, particularly in surgical oncology, commonly use this device.
What are the FDA-cleared indications?
The device is cleared for use in tumor ablation procedures, targeting tumors accessible via electrosurgical techniques.
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.