đź“‹ FDA Reference
gsi cannula with introducer
General Surgical Innovations
Summary: The GSI Cannula with Introducer is a medical device used primarily in embolization procedures. It is utilized by interventional radiologists and vascular surgeons to facilitate the delivery of embolization coils.
FDA Clearance Information
Pathway
510K
Number
K970201 ↗
Decision Date
April 21, 1997
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The GSI Cannula with Introducer was cleared through the FDA 510(k) pathway on April 21, 1997. Manufactured by General Surgical Innovations, it is classified as a Class 2 device under product code DYB.
What It Is
The GSI Cannula with Introducer is a specialized medical device designed to aid in the delivery of embolization coils during minimally invasive procedures. It consists of a cannula, which is a thin tube, and an introducer that helps guide the cannula into the vascular system. This device is crucial for ensuring precise placement of embolization materials, which are used to block blood flow to certain areas, such as in the treatment of aneurysms or tumors.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in procedures requiring the embolization of blood vessels, such as in the treatment of arteriovenous malformations, aneurysms, or uterine fibroids. The GSI Cannula with Introducer allows for precise navigation and placement of embolization coils, making it an essential tool in these specialties. It is typically used in hospital or outpatient surgical centers where minimally invasive procedures are performed.
Indications for Use
The FDA-cleared indications for the GSI Cannula with Introducer involve its use in embolization procedures. This means it is used to help block blood flow to specific areas, which can be beneficial in treating conditions like aneurysms, tumors, or abnormal blood vessel formations.
Practical Considerations
The GSI Cannula with Introducer comes in various sizes to accommodate different vascular anatomies and procedural needs. It is compatible with standard embolization coils and requires careful handling to ensure accurate placement. Clinicians should be trained in its use to maximize procedural success and minimize complications.
Frequently Asked Questions
What is the GSI Cannula with Introducer used for?
It is used to facilitate the delivery of embolization coils during procedures aimed at blocking blood flow to certain areas, such as in treating aneurysms or tumors.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in minimally invasive embolization procedures.
What are the FDA-cleared indications?
The device is cleared for use in embolization procedures to block blood flow to specific areas, aiding in the treatment of conditions like aneurysms and tumors.
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.