đź“Š Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use as a patient-return electrode for electrosurgical procedures.
- Intended for adult and pediatric patient applications as specified by the device labeling.
- Use with compatible electrosurgical generators and accessories according to the manufacturer's instructions.
Clinical Applications
- Providing the return pathway for monopolar electrosurgery.
- Use during electrosurgical procedures involving adult patients.
- Use during electrosurgical procedures involving pediatric patients.
- Supporting safe dispersal of electrical current through the patient-return electrode.
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.
Practical Considerations
- The plate must be correctly sized, positioned, and fully adhered to clean, intact skin according to the manufacturer's instructions.
- It should be used only with compatible electrosurgical generators, cables, and accessories.
- Avoid placement over scars, bony prominences, implanted metal, excessive hair, wounds, or areas with poor tissue contact unless the labeling specifically permits it.
- This is not an MRI device or an implant; it should be removed before MRI and should not be used during MRI.
- Inspect the plate and cable before use and discontinue use if there is damage, poor adhesion, excessive heating, or an electrosurgical alarm.
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.