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icerod cx cryoablation needle
Galil Medical
Summary: The icerod cx cryoablation needle by Galil Medical is a device used for cryoablation of tumors. It is primarily used in renal and pancreatic cancer cases. Key evidence includes studies on tracking renal tumors and managing abdominal pain in pancreatic cancer.
FDA Clearance Information
Pathway
510K
Number
K140584 ↗
Decision Date
March 31, 2014
Product Code
GEH
Device Class
Class 2
Evidence
0 studies
The icerod cx cryoablation needle was cleared by the FDA via the 510(k) pathway on March 31, 2014. It is manufactured by Galil Medical and classified as a Class 2 device under product code GEH.
What It Is
The icerod cx cryoablation needle is a medical device designed for the cryoablation of tumors. It works by applying extreme cold to destroy abnormal tissue, and is intended for use in oncological procedures.
Clinical Applications
This device is commonly used in the treatment of renal tumors and for managing abdominal pain associated with pancreatic cancer. It is employed in scenarios where minimally invasive tumor ablation is indicated.
Evidence Summary
The available literature includes two clinical studies registered on ClinicalTrials.gov. These studies focus on renal tumor tracking post-cryoablation and the safety and efficacy of cryoablation for abdominal pain in pancreatic cancer.
Reported Outcomes
Published studies report on the efficacy of the icerod cx cryoablation needle in managing renal tumors and alleviating abdominal pain in pancreatic cancer. However, specific outcomes and efficacy metrics are not detailed in the provided evidence.
Safety Profile
Reported complications include general risks associated with cryoablation procedures, such as potential damage to surrounding tissues and post-procedural pain. Specific safety data from the studies is not provided.
Evidence Limitations
The evidence is limited by the lack of detailed outcomes and safety data in the provided studies. Further research is needed to establish comprehensive efficacy and safety profiles, as well as long-term outcomes.
Frequently Asked Questions
What are the clinical indications for icerod cx cryoablation needle?
The device is indicated for the cryoablation of tumors, particularly in renal and pancreatic cancer cases.
What outcomes have been reported in clinical studies?
The studies focus on renal tumor tracking and pain management in pancreatic cancer, but specific outcomes are not detailed.
What complications have been reported?
Reported complications include risks typical of cryoablation, such as tissue damage and post-procedural pain.
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.