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acufex r tag tm
Acufex Microsurgical
Summary: The Acufex R Tag TM is a medical device used in uterine fibroid embolization procedures. It is typically utilized by interventional radiologists to treat patients with symptomatic uterine fibroids.
FDA Clearance Information
Pathway
510K
Number
K911293 ↗
Decision Date
July 21, 1993
Product Code
JDR
Device Class
Class 2
Evidence
0 studies
The Acufex R Tag TM was cleared through the FDA 510k pathway on July 21, 1993. Manufactured by Acufex Microsurgical, it is classified as a Class 2 device under product code JDR.
What It Is
The Acufex R Tag TM is a specialized device used in minimally invasive procedures to treat uterine fibroids. It functions by aiding in the embolization process, where blood supply to fibroids is blocked, leading to their shrinkage. This device is designed to be used in conjunction with imaging technology to ensure precise delivery of embolic agents.
Clinical Applications
The Acufex R Tag TM is commonly used in interventional radiology settings, particularly for uterine fibroid embolization. This procedure is often performed in hospitals or specialized outpatient centers. It is primarily used for women suffering from symptomatic uterine fibroids, providing a less invasive alternative to surgical options like hysterectomy.
Indications for Use
The device is indicated for use in patients with uterine fibroids, which are non-cancerous growths in the uterus that can cause symptoms like heavy menstrual bleeding, pelvic pain, and pressure. It is suitable for patients seeking a minimally invasive treatment option.
Practical Considerations
The Acufex R Tag TM is typically compatible with standard embolization catheters and requires fluoroscopic guidance for accurate placement. Clinicians should be trained in embolization techniques and familiar with the anatomy of the uterine vasculature.
Frequently Asked Questions
What is Acufex R Tag TM used for?
The Acufex R Tag TM is used for uterine fibroid embolization, a procedure to treat symptomatic uterine fibroids by blocking their blood supply.
What specialties typically use this device?
Interventional radiologists typically use this device in the context of minimally invasive procedures.
What are the FDA-cleared indications?
The device is cleared for use in procedures aimed at treating uterine fibroids, specifically through embolization techniques.
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.