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uresil dilator
Uresil
Summary: The Uresil Dilator is a medical device used for dilating tissues during procedures, primarily by interventional radiologists and surgeons. It aids in creating access for catheters or other instruments.
FDA Clearance Information
Pathway
510K
Number
K942191 ↗
Decision Date
September 21, 1994
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Uresil Dilator was cleared through the FDA 510(k) pathway on September 21, 1994. Manufactured by Uresil, it is classified as a Class 2 device under product code DYB.
What It Is
The Uresil Dilator is a medical tool designed to facilitate the dilation of tissues, allowing for the insertion of catheters or other medical instruments. It is typically used in minimally invasive procedures to ensure safe and effective access to targeted areas within the body. The device is engineered to provide controlled and gradual dilation, minimizing trauma to surrounding tissues.
Clinical Applications
Commonly used in interventional radiology and surgical procedures, the Uresil Dilator is essential for procedures requiring vascular access, such as the placement of embolization coils. It is used in hospital settings, particularly in operating rooms and interventional suites, and is suitable for a wide range of patient populations requiring minimally invasive interventions.
Indications for Use
The Uresil Dilator is indicated for use in procedures where tissue dilation is necessary to facilitate the insertion of medical instruments. It is particularly useful in patients undergoing procedures that require vascular or other internal access.
Practical Considerations
The Uresil Dilator comes in various sizes to accommodate different anatomical requirements and procedural needs. It is compatible with standard catheterization techniques and should be used by trained professionals familiar with its application to ensure optimal outcomes.
Frequently Asked Questions
What is the Uresil Dilator used for?
The Uresil Dilator is used for dilating tissues to allow the insertion of catheters or other instruments during medical procedures.
What specialties typically use this device?
Interventional radiologists and surgeons commonly use the Uresil Dilator in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring tissue dilation to facilitate instrument insertion, such as vascular access.
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.