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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 ?
510(k)
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.
FDA-Cleared Indications
- The FDA record lists the indication as "Statement," without a complete indication statement in the supplied record.
- The device was cleared through the 510(k) pathway as a Class II device under product code HRX.
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.
Practical Considerations
- Confirm the complete FDA labeling and manufacturer instructions before clinical use; the supplied record does not include the actual indication statement.
- Do not assume compatibility with embolic agents, catheters, guidewires, delivery systems, or other accessories without verifying the device labeling.
- The available information does not establish the device's MRI safety status. Check current labeling for MR Safe, MR Conditional, or MR Unsafe information.
- Use only according to the cleared labeling, including any specified patient-selection criteria, anatomical limitations, handling instructions, and contraindications.
- The supplied record does not identify device dimensions, available sizes, materials, sterilization method, or single-use status.
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.