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acufex suretac r pac
Acufex Microsurgical
Summary: The Acufex Suretac R Pac is a surgical device used in procedures like uterine fibroid embolization. It is primarily utilized by specialists in gynecology and interventional radiology.
FDA Clearance Information
Pathway
510K
Number
K930538 ↗
Decision Date
September 13, 1993
Product Code
JDR
Device Class
Class 2
Evidence
0 studies
The Acufex Suretac R Pac was cleared through the FDA 510(k) pathway on September 13, 1993. It is manufactured by Acufex Microsurgical and is classified as a Class 2 device.
What It Is
The Acufex Suretac R Pac is a medical device designed for use in minimally invasive surgical procedures. It facilitates the embolization of uterine fibroids by delivering embolic agents to the target site. This device aids in reducing fibroid size and alleviating symptoms, providing an alternative to more invasive surgical options.
Clinical Applications
Commonly used in the context of uterine fibroid embolization, the Acufex Suretac R Pac is employed in gynecological and interventional radiology settings. It is particularly useful for patients seeking a minimally invasive approach to manage symptomatic uterine fibroids. The device is typically used in hospital or outpatient surgical centers by trained specialists.
Indications for Use
The device is indicated for patients with uterine fibroids who require embolization to manage symptoms such as heavy menstrual bleeding or pelvic pain. It is suitable for those who prefer a less invasive option compared to traditional surgery.
Practical Considerations
The Acufex Suretac R Pac is compatible with standard embolization techniques and is available in various sizes to accommodate different patient anatomies. Clinicians should be trained in its use to ensure optimal outcomes and minimize complications.
Frequently Asked Questions
What is Acufex Suretac R Pac used for?
It is used for uterine fibroid embolization, a procedure to reduce fibroid size and alleviate symptoms.
What specialties typically use this device?
Gynecology and interventional radiology specialists typically use this device.
What are the FDA-cleared indications?
It is indicated for the embolization of uterine fibroids to manage symptoms like heavy bleeding and pelvic pain.
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.