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neutralect adult standard return rem paediatric electrosurgery plate modification
Msb
Summary: The neutralect adult standard return rem paediatric electrosurgery plate modification by Msb is an FDA-cleared device used in electrosurgery. It is primarily indicated for prostate-artery-embolization. Key evidence includes 9 studies exploring its clinical applications.
FDA Clearance Information
Pathway
510K
Number
K955261 ↗
Decision Date
January 30, 1996
Product Code
GEI
Device Class
Class 2
Evidence
0 studies
The device was cleared by the FDA through the 510(k) pathway on January 30, 1996. It is manufactured by Msb and classified as a Class 2 medical device under product code GEI.
What It Is
This device is a modification of an electrosurgery plate designed for use in both adult and paediatric populations. It facilitates the safe return of electrical current during electrosurgical procedures, particularly in prostate-artery-embolization.
Clinical Applications
Commonly used in procedures requiring electrosurgery, this device is particularly relevant in prostate-artery-embolization. It ensures effective current return, minimizing the risk of burns or other complications.
Evidence Summary
The literature includes 9 studies, comprising various study types such as RCTs and systematic reviews. These studies span from 2021 to 2025, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report varied outcomes, with some indicating improved procedural efficiency and safety in electrosurgical applications. However, specific efficacy findings related to prostate-artery-embolization are not detailed in the provided evidence.
Safety Profile
Reported complications include general risks associated with electrosurgery, such as thermal injury. However, the provided evidence does not specify detailed safety outcomes for this device.
Evidence Limitations
The evidence lacks detailed efficacy and safety outcomes specific to the device's use in prostate-artery-embolization. Further research is needed to establish comprehensive safety profiles and long-term efficacy.
Frequently Asked Questions
What are the clinical indications for neutralect adult standard return rem paediatric electrosurgery plate modification?
The device is indicated for use in electrosurgery, particularly in prostate-artery-embolization.
What outcomes have been reported in clinical studies?
Studies report improved procedural efficiency and safety, though specific outcomes for prostate-artery-embolization are not detailed.
What complications have been reported?
Reported complications include general risks of electrosurgery, such as thermal injury, but specific safety data for this device is limited.
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.