đź“‹ FDA Reference
acufex suretac ixc systems
Acufex Microsurgical
Summary: The Acufex Suretac IXC Systems is a medical device used primarily in uterine fibroid embolization procedures. It is typically utilized by interventional radiologists and gynecologists to treat patients with symptomatic uterine fibroids.
FDA Clearance Information
Pathway
510K
Number
K940623 ↗
Decision Date
April 26, 1994
Product Code
HRX
Device Class
Class 2
Evidence
0 studies
The Acufex Suretac IXC Systems was cleared through the FDA 510(k) pathway on April 26, 1994, by Acufex Microsurgical. It is classified as a Class 2 device under product code HRX.
What It Is
The Acufex Suretac IXC Systems is a specialized device designed for use in minimally invasive procedures, particularly uterine fibroid embolization. It functions by delivering embolic agents to the uterine arteries, effectively reducing blood supply to fibroids and causing them to shrink. This device is part of a broader category of tools used in interventional radiology to manage vascular conditions.
Clinical Applications
Commonly used in the context of uterine fibroid embolization, the Acufex Suretac IXC Systems is employed in interventional radiology suites and operating rooms. It is particularly relevant for patients suffering from symptomatic fibroids, offering a less invasive alternative to surgical options like hysterectomy. The device is typically used by interventional radiologists and gynecologists who specialize in minimally invasive procedures.
Indications for Use
The FDA-cleared indication for the Acufex Suretac IXC Systems is for use in uterine fibroid embolization. This means it is intended for patients with uterine fibroids causing symptoms such as heavy menstrual bleeding or pelvic pain, providing a treatment option that preserves the uterus.
Practical Considerations
The Acufex Suretac IXC Systems is compatible with standard embolization techniques and is designed for use with commonly available embolic agents. Clinicians should ensure proper sizing and compatibility with the patient's anatomy to optimize outcomes. Familiarity with interventional radiology techniques is essential for effective use.
Frequently Asked Questions
What is Acufex Suretac IXC Systems used for?
The device is used for uterine fibroid embolization, a procedure to treat symptomatic uterine fibroids by reducing their blood supply.
What specialties typically use this device?
Interventional radiologists and gynecologists specializing in minimally invasive procedures commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in uterine fibroid embolization, targeting patients with symptomatic uterine fibroids.
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.