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bcd-hpp41c interface
Dynatech
Summary: The bcd-hpp41c interface by Dynatech is an ablation device for tumor treatment. It was FDA cleared via the 510k pathway in 1981. Key evidence highlights advancements in neural and mucosa-interfacing technologies.
FDA Clearance Information
Pathway
510K
Number
K810968 ↗
Decision Date
April 23, 1981
Product Code
JQP
Device Class
Class 1
Evidence
0 studies
The bcd-hpp41c interface was cleared by the FDA through the 510k pathway on April 23, 1981. It is manufactured by Dynatech and classified as a Class 1 device under product code JQP.
What It Is
The bcd-hpp41c interface is a medical device designed for tumor ablation. It functions by delivering targeted energy to destroy tumor cells, and is intended for use in clinical settings where tumor reduction is necessary.
Clinical Applications
Commonly used in oncology, the bcd-hpp41c interface is applied in scenarios requiring precise tumor ablation. It is particularly useful in cases where minimally invasive procedures are preferred.
Evidence Summary
The available literature includes 10 studies, with a mix of review articles and experimental research, published up to 2024. These studies explore advancements in neural interfaces and bioelectronics.
Reported Outcomes
Published studies report advancements in the development of neural interfaces and bioelectronics, highlighting the potential for improved biocompatibility and functionality. However, specific outcomes related to the bcd-hpp41c interface's efficacy in tumor ablation are not detailed in the provided evidence.
Safety Profile
Reported complications include challenges with device localization, retention, and removal, as well as issues with power and data transfer in mucosa-interfacing electronics. Specific safety data for the bcd-hpp41c interface is not detailed in the provided evidence.
Evidence Limitations
The evidence lacks specific data on the bcd-hpp41c interface's efficacy and safety in tumor ablation. Further research is needed to evaluate its clinical outcomes and long-term safety profile.
Frequently Asked Questions
What are the clinical indications for bcd-hpp41c interface?
The clinical indications for the bcd-hpp41c interface are detailed in the FDA documentation, primarily focusing on tumor ablation.
What outcomes have been reported in clinical studies?
The studies highlight advancements in neural and mucosa-interfacing technologies, but specific outcomes for the bcd-hpp41c interface are not detailed.
What complications have been reported?
Reported complications include issues with device localization and retention in mucosa-interfacing electronics, though specific data for the bcd-hpp41c interface is not provided.
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.