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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 ?
510(k)
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.
FDA-Cleared Indications
- The FDA record identifies the Acufex T-Bar as a surgical instrument under product code HRX.
- The supplied FDA indication field contains only the word "Statement" and does not provide a specific clinical indication.
Clinical Applications
- Use as a surgical instrument within the procedures specified in the device's complete FDA-cleared labeling.
- Use by trained surgical personnel when the instrument is appropriate for the planned operative technique.
Practical Considerations
- The complete FDA 510(k) summary, labeling, and instructions for use should be reviewed before assigning a specific procedure or clinical application.
- The available record does not establish that this device is intended for uterine fibroid embolization, embolic-agent delivery, vascular access, or catheter manipulation.
- Confirm the device's dimensions, configuration, reusable or single-use status, cleaning requirements, and sterilization instructions in the manufacturer labeling.
- MRI safety has not been established from the supplied record; do not bring the instrument into an MRI environment unless its MR labeling has been verified.
- Use should be limited to trained clinicians who can assess compatibility with the operative approach and patient anatomy.
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.