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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
510K
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.
Clinical Applications
This device is commonly used in surgical oncology for the ablation of tumors in various organs. It is particularly useful in minimally invasive procedures where precise energy delivery is critical. Surgeons and interventional radiologists in hospital settings often use this device for patients with solid tumors requiring ablation.
Indications for Use
The FDA-cleared indications for this device include its use in ablation procedures for tumor treatment. It is intended for patients with tumors that are accessible via electrosurgical techniques.
Practical Considerations
The scb Valleylab Force FX Interface Unit is compatible with various electrosurgical generators. Clinicians should ensure proper setup and calibration before procedures. It is important to follow manufacturer guidelines for optimal performance and safety.
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.