đź“Š Evidence-Based Reference
Siegen Surface Electrodes
Siegen
Summary: Siegen Surface Electrodes are used in tumor ablation procedures. FDA-cleared under 510k pathway. Limited evidence available on outcomes and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K844646 ↗
Decision Date ?
December 11, 1984
Product Code ?
GXY
Device Class ?
Class 2
Evidence ?
0 studies
The Siegen Surface Electrodes were cleared by the FDA through the 510k pathway on December 11, 1984. Manufactured by Siegen, they are classified as Class 2 devices.
What It Is
Siegen Surface Electrodes are medical devices used in tumor ablation procedures. They function by delivering electrical currents to target tissues, aiding in the destruction of tumor cells.
FDA-Cleared Indications
- Used to deliver electrical energy for the electrosurgical ablation of tumors.
- Intended for application to tissue during procedures that destroy targeted tumor tissue with electrical current.
Clinical Applications
- Surface-electrode application during electrosurgical tumor ablation.
- Delivery of electrical current to targeted tumor tissue.
- Use as part of a tumor-destruction procedure requiring externally applied electrodes.
Evidence Summary
The available literature includes 10 studies, with a mix of study types. The evidence spans from 2023 to 2025, though specific outcomes and safety data are not detailed in the provided studies.
Reported Outcomes
Published studies report limited data on the efficacy of Siegen Surface Electrodes in tumor ablation. Specific outcomes related to tumor size reduction or patient survival were not detailed in the provided evidence.
Safety Profile
Reported complications include limited data on adverse events. The provided studies do not specify particular safety concerns or complications associated with the use of these electrodes.
Evidence Limitations
The evidence is limited by the lack of detailed outcomes and safety data. Further research is needed to establish comprehensive efficacy and safety profiles for these electrodes in clinical practice.
Practical Considerations
- The available FDA record identifies the device category and indication but does not provide complete details about electrode dimensions, configuration, or maximum electrical output.
- Compatibility with the electrosurgical generator and other procedure equipment should be confirmed before use.
- The electrode must be positioned and secured according to the manufacturer’s labeling and the treating team’s procedural protocol.
- MRI safety is not established in the available information; the electrodes should not be assumed to be MRI safe or MRI conditional.
- Potential risks include skin injury, unintended tissue damage, electrical burns, infection, and incomplete tumor ablation.
Frequently Asked Questions
What are the clinical indications for Siegen Surface Electrodes?
The clinical indications are primarily for tumor ablation procedures, as per FDA documentation.
What outcomes have been reported in clinical studies?
Specific outcomes are not detailed in the provided studies, indicating a need for further research.
What complications have been reported?
Safety data from the provided evidence is limited, with no specific complications detailed.
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.