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gore tunneler modification
W.L. Gore & Associates
Summary: The Gore Tunneler Modification is a medical device used primarily for the placement of embolization coils. It is utilized by interventional radiologists and vascular surgeons to facilitate minimally invasive procedures.
FDA Clearance Information
Pathway
510K
Number
K920998 ↗
Decision Date
June 3, 1992
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Gore Tunneler Modification was cleared through the FDA 510(k) pathway on June 3, 1992. Manufactured by W.L. Gore & Associates, it is classified as a Class II device under product code DYB.
What It Is
The Gore Tunneler Modification is a specialized medical device designed to assist in the placement of embolization coils during vascular procedures. It provides a means to create a pathway for the delivery of coils to target sites within the vasculature. This device is particularly useful in procedures requiring precision and control in accessing difficult-to-reach vascular regions.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is employed in procedures aimed at treating aneurysms, arteriovenous malformations, and other vascular anomalies. The Gore Tunneler Modification is suitable for use in both hospital and outpatient settings, catering to a diverse patient population requiring embolization therapy.
Indications for Use
The FDA-cleared indications for the Gore Tunneler Modification involve its use in the placement of embolization coils. This is typically for patients with vascular conditions that necessitate the occlusion of blood vessels to prevent or treat bleeding or to reduce blood flow to a specific area.
Practical Considerations
When using the Gore Tunneler Modification, clinicians should consider the compatibility of the device with various coil sizes and types. Proper technique is essential to ensure successful coil deployment, and familiarity with the device's handling characteristics can enhance procedural efficiency.
Frequently Asked Questions
What is Gore Tunneler Modification used for?
It is used for the placement of embolization coils in vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in the placement of embolization coils to treat vascular conditions.
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.