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electrode market disposable surface electrodes
Electrode Market
Summary: Electrode Market disposable surface electrodes are used for tumor ablation. FDA-cleared under 510k pathway. Limited direct evidence available.
FDA Clearance Information
Pathway
510K
Number
K211839 ↗
Decision Date
July 28, 2021
Product Code
GXY
Device Class
Class 2
Evidence
0 studies
The Electrode Market disposable surface electrodes were cleared by the FDA via the 510k pathway on July 28, 2021. Manufactured by Electrode Market, they are classified as Class 2 medical devices.
What It Is
These are disposable surface electrodes designed for use in tumor ablation procedures. They function by delivering electrical energy to target tissues, aiding in the destruction of tumor cells.
Clinical Applications
Commonly used in oncology for the ablation of tumors, these electrodes are applied in procedures requiring precise delivery of electrical energy to tumor sites.
Evidence Summary
The available literature includes 5 studies, though none directly pertain to the device's clinical efficacy or safety. The studies range from 2009 to 2023 and cover various unrelated topics.
Reported Outcomes
Published studies report no direct outcomes related to the Electrode Market disposable surface electrodes. The evidence provided does not include specific efficacy findings for this device.
Safety Profile
Reported complications include no direct safety data from the provided studies. The evidence does not offer specific safety outcomes related to the use of these electrodes.
Evidence Limitations
There is a lack of direct clinical evidence evaluating the efficacy and safety of these electrodes. Further research is needed to establish comprehensive clinical outcomes and safety profiles.
Frequently Asked Questions
What are the clinical indications for electrode market disposable surface electrodes?
These electrodes are indicated for use in tumor ablation procedures.
What outcomes have been reported in clinical studies?
No specific outcomes related to these electrodes have been reported in the provided studies.
What complications have been reported?
The provided evidence does not include specific safety data or reported complications for these electrodes.
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.