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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
510K
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.
Clinical Applications
Acufex Probes are commonly used in uterine fibroid embolization procedures, a minimally invasive treatment for uterine fibroids. These procedures are typically performed in hospital settings or specialized outpatient centers by gynecologists or interventional radiologists. The probes are essential for navigating and manipulating the uterine vasculature to deliver embolic agents effectively.
Indications for Use
The FDA-cleared indications for Acufex Probes include their use in procedures aimed at treating uterine fibroids. They are specifically designed to aid in the embolization process, which is a treatment option for women experiencing symptoms from fibroids.
Practical Considerations
Acufex Probes come in various sizes to accommodate different patient anatomies and procedural needs. They are compatible with standard embolization techniques and require careful handling to maintain their precision. Clinicians should be trained in their use to ensure optimal outcomes.
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.