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rfa a-300
Scanditronix
Summary: The RFA A-300 by Scanditronix is a Class 2 ablation device for tumor treatment, FDA-cleared via 510(k) in 1994. Limited evidence available with no specific outcomes or safety data reported.
FDA Clearance Information
Pathway
510K
Number
K934303 ↗
Decision Date
August 9, 1994
Product Code
IYE
Device Class
Class 2
Evidence
0 studies
The RFA A-300, manufactured by Scanditronix, received FDA clearance through the 510(k) pathway on August 9, 1994. It is classified as a Class 2 medical device under product code IYE.
What It Is
The RFA A-300 is a radiofrequency ablation device designed for the treatment of tumors. It uses thermal energy to ablate tumor tissues, providing a minimally invasive option for tumor management.
Clinical Applications
Commonly used in oncology settings, the RFA A-300 is applied in scenarios where tumor ablation is indicated, such as inoperable tumors or as an adjunct to surgical resection.
Evidence Summary
The available literature includes two studies, though neither provides specific outcomes or safety data. The studies span from 1997 to an unspecified date, focusing on related clinical applications.
Reported Outcomes
Published studies report no specific efficacy findings for the RFA A-300. The evidence provided does not include detailed outcomes related to the device's performance in clinical settings.
Safety Profile
Reported complications include no specific safety data from the provided evidence. The studies do not detail adverse events or complications associated with the RFA A-300.
Evidence Limitations
The evidence for the RFA A-300 is limited, with no detailed outcomes or safety data reported. Further research is needed to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for RFA A-300?
The RFA A-300 is indicated for tumor ablation, particularly in cases where surgical options are limited or as an adjunct to surgery.
What outcomes have been reported in clinical studies?
The provided evidence does not report specific outcomes for the RFA A-300.
What complications have been reported?
The evidence does not provide specific safety data or reported complications for the RFA A-300.
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.