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bio-interfaces inc bii-plast
Bio-Interfaces
Summary: The bio-interfaces inc bii-plast is an ablation device used for tumor treatment. It is FDA 510k cleared and supported by 8 studies, focusing on its bio-interface capabilities.
FDA Clearance Information
Pathway
510K
Number
K954763 ↗
Decision Date
January 4, 1996
Product Code
LYC
Device Class
Class 2
Evidence
0 studies
The bio-interfaces inc bii-plast was cleared through the FDA 510k pathway on January 4, 1996. It is manufactured by Bio-Interfaces and classified as a Class 2 device.
What It Is
The bio-interfaces inc bii-plast is a medical device designed for tumor ablation. It utilizes advanced bio-interface technology to target and treat tumors effectively.
Clinical Applications
Commonly used in oncology, the device is applied in scenarios requiring precise tumor ablation. It is particularly useful in cases where traditional surgical methods are not feasible.
Evidence Summary
The literature includes 8 studies, comprising various study types, conducted between 2021 and 2024. These studies explore the device's bio-interface properties and clinical applications.
Reported Outcomes
Published studies report the device's efficacy in creating conductive polymers in vivo, enhancing bioelectronic applications. Other studies highlight its role in manipulating cellular processes and improving bio-interface interactions.
Safety Profile
Reported complications include limited understanding of the interplay between substrate topography and cellular behavior. No specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by a lack of detailed clinical outcomes and safety data. Further research is needed to fully understand the device's long-term efficacy and safety profile.
Frequently Asked Questions
What are the clinical indications for bio-interfaces inc bii-plast?
The device is indicated for tumor ablation, particularly in cases where traditional surgery is not suitable.
What outcomes have been reported in clinical studies?
Studies report enhanced bio-interface capabilities and successful in vivo polymerization for bioelectronic applications.
What complications have been reported?
Reported complications include a limited understanding of cellular interactions with the device's substrate topography.
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.