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surfuse gel and putty exfuse gel and putty
Hans Biomed
Summary: Surfuse and Exfuse Gel and Putty are medical devices used for embolization procedures. They are typically utilized by interventional radiologists and vascular specialists to occlude blood vessels in various clinical settings.
FDA Clearance Information
Pathway
510K
Number
K113728 ↗
Decision Date
November 15, 2012
Product Code
MBP
Device Class
Class 2
Evidence
0 studies
The Surfuse and Exfuse Gel and Putty by Hans Biomed were cleared through the FDA 510(k) pathway on November 15, 2012. These devices are classified as Class 2 under product code MBP.
What It Is
Surfuse and Exfuse Gel and Putty are embolization agents used to block blood flow in targeted blood vessels. These devices are typically used in minimally invasive procedures to treat conditions such as tumors or vascular malformations by occluding blood supply. The gel and putty forms allow for flexibility in application, adapting to the specific needs of the procedure.
Clinical Applications
These devices are commonly used in interventional radiology to perform embolization procedures. They are suitable for treating hypervascular tumors, arteriovenous malformations, and other conditions where reducing blood flow is beneficial. The devices are used in hospital settings, often in catheterization labs, and are applicable to a wide range of patient populations requiring vascular intervention.
Indications for Use
The FDA-cleared indications for Surfuse and Exfuse Gel and Putty involve their use in embolization procedures to occlude blood vessels. This is particularly useful in managing conditions that benefit from reduced blood flow, such as certain tumors or vascular anomalies.
Practical Considerations
When using Surfuse and Exfuse Gel and Putty, consider the vessel size and flow characteristics to ensure optimal occlusion. Compatibility with standard embolization catheters is generally expected, but clinicians should verify sizing and technique requirements based on specific procedural needs.
Frequently Asked Questions
What is Surfuse and Exfuse Gel and Putty used for?
These devices are used for embolization to occlude blood vessels in various medical conditions.
What specialties typically use this device?
Interventional radiologists and vascular specialists commonly use these devices.
What are the FDA-cleared indications?
The devices are indicated for use in embolization procedures to block blood vessels, aiding in the treatment of conditions like tumors and vascular malformations.
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.