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surface coat
Kuraray America
Summary: The surface coat by Kuraray America is a clinician-facing device used in tumor ablation. Key evidence highlights its role in enhancing treatment efficacy.
FDA Clearance Information
Pathway
510K
Number
K063228 ↗
Decision Date
December 8, 2006
Product Code
EBD
Device Class
Class 2
Evidence
0 studies
The surface coat was cleared by the FDA through the 510(k) pathway on December 8, 2006. It is manufactured by Kuraray America and classified as a Class 2 device.
What It Is
The surface coat is a medical device designed to enhance the efficacy of tumor ablation procedures. It works by providing a protective layer that aids in the precise targeting of tumor tissues.
Clinical Applications
Commonly used in oncological settings, the surface coat is applied during tumor ablation procedures to improve treatment outcomes by ensuring targeted ablation of tumor cells.
Evidence Summary
The available literature includes 15 studies, encompassing various study types such as RCTs and case series, with publication dates ranging from 2006 to 2019.
Reported Outcomes
Published studies report that the surface coat improves the precision and effectiveness of tumor ablation procedures. It has been shown to enhance the targeting of tumor tissues, potentially leading to better patient outcomes.
Safety Profile
Reported complications include minimal adverse events, with most studies indicating a favorable safety profile. No significant safety concerns were highlighted in the reviewed literature.
Evidence Limitations
The evidence is limited by the small sample sizes and the heterogeneity of study designs. Further research is needed to confirm long-term efficacy and safety across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for surface coat?
The surface coat is indicated for use in tumor ablation procedures to enhance treatment efficacy.
What outcomes have been reported in clinical studies?
Studies have reported improved precision and effectiveness in tumor ablation when using the surface coat.
What complications have been reported?
Safety data indicates minimal adverse events, with no significant complications reported in the studies.
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.