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acufex adjustable-length cannula
Acufex Microsurgical
Summary: The Acufex Adjustable-Length Cannula is a surgical tool used primarily in procedures like uterine fibroid embolization. It is utilized by surgeons in gynecological settings to facilitate precise access and delivery of embolic agents.
FDA Clearance Information
Pathway
510K
Number
K934181 ↗
Decision Date
March 23, 1994
Product Code
HRX
Device Class
Class 2
Evidence
0 studies
The Acufex Adjustable-Length Cannula was cleared via the FDA 510(k) pathway on March 23, 1994. Manufactured by Acufex Microsurgical, it is classified as a Class 2 device under product code HRX.
What It Is
The Acufex Adjustable-Length Cannula is a specialized surgical instrument designed to provide adjustable access during procedures. It allows for precise control over the length of the cannula, facilitating accurate delivery of materials or instruments to targeted sites. This is particularly useful in minimally invasive procedures where precision is critical.
Clinical Applications
This device is commonly used in gynecological procedures, such as uterine fibroid embolization, where it aids in the delivery of embolic agents to the uterine arteries. It is typically employed in hospital settings by interventional radiologists or gynecologists. The adjustable length feature makes it versatile for various anatomical challenges and patient sizes.
Indications for Use
The FDA-cleared indication for the Acufex Adjustable-Length Cannula is for use in uterine fibroid embolization procedures. This means it is intended for patients with uterine fibroids, where the goal is to reduce fibroid size and symptoms by blocking blood supply.
Practical Considerations
The cannula's adjustable length feature allows for flexibility in different procedural contexts, accommodating various patient anatomies. It is important for clinicians to ensure compatibility with other surgical instruments and embolic agents used during procedures. Proper technique in adjusting and securing the cannula length is crucial for optimal outcomes.
Frequently Asked Questions
What is the Acufex Adjustable-Length Cannula used for?
It is used primarily in uterine fibroid embolization to deliver embolic agents to the uterine arteries.
What specialties typically use this device?
Interventional radiologists and gynecologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in uterine fibroid embolization procedures.
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.