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Acufex Tag Delivery System
Acufex Microsurgical
Summary: The Acufex Tag Delivery System is a medical device used in uterine fibroid embolization procedures. It is typically used by interventional radiologists to treat patients with symptomatic uterine fibroids.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K953276 ↗
Decision Date ?
October 5, 1995
Product Code ?
JDR
Device Class ?
Class 2
Evidence ?
0 studies
The Acufex Tag Delivery System was cleared through the FDA 510k pathway on October 5, 1995. Manufactured by Acufex Microsurgical, it is classified as a Class 2 device under the product code JDR.
What It Is
The Acufex Tag Delivery System is designed to assist in the delivery of embolic agents during uterine fibroid embolization procedures. It facilitates precise placement of embolic materials to occlude blood vessels supplying uterine fibroids, thus reducing their size and alleviating symptoms. The system is engineered to provide controlled delivery, enhancing procedural accuracy and patient outcomes.
FDA-Cleared Indications
- Use in uterine fibroid embolization procedures.
- Delivery of embolic agents for occlusion of blood vessels supplying uterine fibroids.
Clinical Applications
- Catheter-based delivery of embolic agents during uterine fibroid embolization.
- Treatment of symptomatic uterine fibroids when embolization is selected as a management option.
- Controlled placement of embolic material in the uterine arterial circulation.
Practical Considerations
- The available FDA record identifies uterine fibroid embolization as the indication; use outside that indication should not be assumed to be cleared.
- The system should be selected and handled according to the current manufacturer’s instructions for use, including available sizes and compatibility with the intended embolic agent.
- Use requires catheter-based vascular access, fluoroscopic imaging, and clinicians trained in uterine artery embolization.
- Contraindications, warnings, preparation requirements, and device-specific MRI information should be confirmed in the current labeling. MRI safety cannot be determined from the 1995 510(k) summary alone.
- Potential procedural risks include vascular injury, bleeding, infection, non-target embolization, allergic reaction to contrast, and complications related to uterine fibroid embolization.
Frequently Asked Questions
What is the Acufex Tag Delivery System used for?
It is used for delivering embolic agents during uterine fibroid embolization procedures.
What specialties typically use this device?
Interventional radiologists primarily use this device in the treatment of uterine fibroids.
What are the FDA-cleared indications?
The device is indicated for use in uterine fibroid embolization to treat 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.