đź“‹ FDA Reference
9293 1 Interface Module
S & W Medico Teknik
Summary: The 9293 1 interface module is a Class 2 medical device used in tumor ablation procedures. It is typically utilized by oncologists and interventional radiologists in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K923418 ↗
Decision Date ?
February 23, 1993
Product Code ?
DQA
Device Class ?
Class 2
Evidence ?
0 studies
The 9293 1 interface module by S & W Medico Teknik was cleared via the FDA 510(k) pathway on February 23, 1993. It is classified as a Class 2 device under product code DQA.
What It Is
The 9293 1 interface module is a medical device designed to facilitate tumor ablation procedures. It acts as a critical component in the delivery of energy to targeted tissues, enabling precise ablation of tumor cells. The device is engineered to integrate with ablation systems, ensuring accurate and controlled energy delivery.
FDA-Cleared Indications
- Used as an interface module in tumor ablation procedures.
- Intended to function with compatible tumor-ablation equipment during clinical treatment.
Clinical Applications
- Interface connection during image-guided ablation of tumor tissue.
- Use with compatible ablation systems in hospital or outpatient clinical settings.
- Support of controlled energy delivery during minimally invasive tumor-ablation procedures.
Practical Considerations
- Confirm compatibility with the specific ablation generator, applicator, cables and accessories before the procedure.
- Follow the manufacturer's instructions for connection, setup, cleaning, handling and maintenance.
- The available record does not establish MRI safety; verify MR Safe, MR Conditional or MR Unsafe labeling before use in or near an MRI environment.
- Use should be limited to the configurations and procedures described in the device labeling and institutional protocols.
- The available FDA summary does not provide reliable details about device dimensions, reusable life, or specific contraindications; consult the original labeling.
Frequently Asked Questions
What is the 9293 1 interface module used for?
The 9293 1 interface module is used for tumor ablation procedures, facilitating the delivery of energy to ablate tumor cells.
What specialties typically use this device?
Oncologists and interventional radiologists typically use this device in tumor ablation procedures.
What are the FDA-cleared indications?
The device is indicated for use in tumor ablation procedures, providing a minimally invasive option for treating solid 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.