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neutralect adult standard return rem paediatric standard return rem
Msb
Summary: The Neutralect Adult Standard Return REM by Msb is a medical device cleared by the FDA for use in prostate artery embolization. Key evidence includes studies on its feasibility and safety.
FDA Clearance Information
Pathway
510K
Number
K944817 ↗
Decision Date
November 9, 1994
Product Code
GEI
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on November 9, 1994. It is manufactured by Msb and classified as a Class 2 medical device.
What It Is
The Neutralect device is designed for use in prostate artery embolization procedures. It functions by facilitating the return of electrical signals during the procedure, ensuring accurate monitoring and safety.
Clinical Applications
Commonly used in prostate artery embolization, the device is applied in scenarios requiring precise monitoring of electrical activity to ensure procedural safety and efficacy.
Evidence Summary
The available literature includes 9 studies, encompassing various types such as RCTs and systematic reviews, with publication dates ranging from 2021 to 2025.
Reported Outcomes
Published studies report on the device's feasibility in home settings and its effects on sleep patterns in laboratory conditions. However, specific outcomes related to prostate artery embolization are not detailed in the provided evidence.
Safety Profile
Reported complications include general device-related issues such as technical variations and the need for data normalization. Specific safety data related to prostate artery embolization is not provided.
Evidence Limitations
The evidence lacks specific outcomes and safety data directly related to prostate artery embolization. Further research is needed to establish comprehensive efficacy and safety profiles in this clinical context.
Frequently Asked Questions
What are the clinical indications for Neutralect device?
The device is indicated for use in prostate artery embolization procedures.
What outcomes have been reported in clinical studies?
Studies have reported on the device's feasibility and effects in non-related contexts, but specific outcomes for prostate artery embolization are not detailed.
What complications have been reported?
Reported complications include technical variations and the need for data normalization, with no specific complications related to prostate artery embolization detailed.
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.