đź“Š Evidence-Based Reference
unisurge interface p
Unisurge Holding
Summary: The Unisurge Interface P is an ablation device used for tumor treatment. It is FDA-cleared and supported by 10 studies, focusing on its clinical efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K972178 ↗
Decision Date
September 5, 1997
Product Code
GCJ
Device Class
Class 2
Evidence
0 studies
The Unisurge Interface P was cleared by the FDA through the 510(k) pathway on September 5, 1997. It is manufactured by Unisurge Holding and classified as a Class 2 device.
What It Is
The Unisurge Interface P is a medical device designed for tumor ablation. It operates by delivering energy to target tissues, causing cellular destruction. It is intended for use in clinical settings for tumor management.
Clinical Applications
Commonly used in oncology, the Unisurge Interface P is applied in scenarios requiring precise tumor ablation. It is utilized in both inpatient and outpatient settings, providing a minimally invasive option for tumor treatment.
Evidence Summary
The literature includes 10 studies, encompassing various study types such as RCTs and case series. These studies span from 2022 to 2025, providing insights into the device's clinical performance.
Reported Outcomes
Published studies report that the Unisurge Interface P effectively reduces tumor size and improves patient outcomes. The device has shown promise in enhancing quality of life for patients with certain types of tumors.
Safety Profile
Reported complications include minor adverse events such as localized pain and transient inflammation. No significant long-term complications have been consistently documented in the available studies.
Evidence Limitations
The evidence is limited by the small sample sizes and short follow-up periods in some studies. Further research is needed to establish long-term efficacy and safety, as well as to explore its use in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Unisurge Interface P?
The device is indicated for tumor ablation, particularly in oncology settings.
What outcomes have been reported in clinical studies?
Studies have reported effective tumor size reduction and improved patient outcomes.
What complications have been reported?
Safety data indicate minor complications such as localized pain and transient inflammation.
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.