đź“‹ FDA Reference
acufex t-bar
Acufex Microsurgical
Summary: The Acufex T-Bar is a surgical instrument used primarily in uterine fibroid embolization procedures. It is utilized by interventional radiologists and gynecologists to aid in precise surgical interventions.
FDA Clearance Information
Pathway
510K
Number
K925573 ↗
Decision Date
May 5, 1993
Product Code
HRX
Device Class
Class 2
Evidence
0 studies
The Acufex T-Bar was cleared through the FDA 510(k) pathway on May 5, 1993. Manufactured by Acufex Microsurgical, it is classified as a Class 2 device under product code HRX.
What It Is
The Acufex T-Bar is a specialized surgical instrument designed to assist in minimally invasive procedures. It is typically used to manipulate or stabilize tissues during surgery, providing precision and control. Its design allows for effective handling in complex surgical environments, particularly in procedures involving embolization.
Clinical Applications
This device is commonly used in uterine fibroid embolization, a procedure performed to reduce the size of uterine fibroids. Interventional radiologists and gynecologists use it in hospital settings to improve patient outcomes by ensuring accurate delivery of embolic agents. It is particularly beneficial for patients with symptomatic fibroids seeking minimally invasive treatment options.
Indications for Use
The FDA indications for the Acufex T-Bar focus on its use in procedures like uterine fibroid embolization. It is intended for patients with uterine fibroids causing symptoms such as heavy bleeding or pelvic pain.
Practical Considerations
The Acufex T-Bar is compatible with standard embolization techniques and is available in various sizes to accommodate different patient anatomies. Clinicians should be familiar with its handling to maximize its benefits during procedures.
Frequently Asked Questions
What is the Acufex T-Bar used for?
The Acufex T-Bar is used in uterine fibroid embolization procedures to assist in the precise manipulation and stabilization of tissues.
What specialties typically use this device?
Interventional radiologists and gynecologists typically use the Acufex T-Bar in their practice.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving uterine fibroid embolization, particularly for patients with symptomatic 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.