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Acufex Probes
Acufex Microsurgical
Summary: Acufex Probes are surgical instruments used primarily in procedures involving uterine fibroid embolization. They are typically utilized by gynecologists and interventional radiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K800274 ↗
Decision Date ?
February 19, 1980
Product Code ?
HXB
Device Class ?
Class 1
Evidence ?
0 studies
The Acufex Probes were cleared through the FDA 510(k) pathway on February 19, 1980. Manufactured by Acufex Microsurgical, they are classified as Class 1 devices under product code HXB.
What It Is
Acufex Probes are precision surgical instruments designed for use in minimally invasive procedures. They are used to manipulate tissues and assist in the embolization of uterine fibroids. These probes are crafted to provide optimal control and precision, which is crucial in delicate surgical environments.
FDA-Cleared Indications
- Use as a surgical instrument in procedures requiring tissue or vessel manipulation.
- Use in uterine fibroid embolization procedures, according to the available device record.
Clinical Applications
- Assisting with catheter-based uterine fibroid embolization.
- Manipulating tissue or vascular structures during minimally invasive gynecologic procedures.
- Supporting positioning or handling tasks during procedures performed under imaging guidance.
Practical Considerations
- Available information indicates that the probes come in multiple sizes; clinicians should select the size appropriate for the anatomy and procedure.
- Use requires appropriate procedural training and careful handling to preserve instrument control and precision.
- Compatibility with embolization catheters, guidewires, and other equipment should be confirmed before the procedure.
- The FDA record supplied does not provide MRI-safety information; MRI labeling should be verified with the current manufacturer documentation.
- Contraindications, sterilization requirements, and reuse status should be checked in the current instructions for use.
Frequently Asked Questions
What is Acufex Probes used for?
Acufex Probes are used in uterine fibroid embolization procedures to assist in the precise delivery of embolic agents.
What specialties typically use this device?
Gynecologists and interventional radiologists typically use Acufex Probes in their practice.
What are the FDA-cleared indications?
The probes are indicated for use in procedures targeting the embolization of 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.