đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
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.
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.
Practical Considerations
- The FDA indication statement supplied for this record is incomplete, so clinicians should consult the original 510(k) summary, labeling, and instructions for use before using the device.
- Do not assume compatibility with embolic agents, catheters, guidewires, or other accessories unless compatibility is specified in the manufacturer’s labeling.
- Device size, configuration, access route, and handling instructions should be verified against the current product documentation.
- MRI safety cannot be determined from the information provided. Confirm MR Safe, MR Conditional, or MR Unsafe status in the manufacturer’s labeling before MRI.
- Use should be limited to trained clinicians who have reviewed the device-specific indications, contraindications, warnings, and instructions for use.
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.