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acufex screw cannula
Smith & Nephew Endoscopy
Summary: The Acufex Screw Cannula is a medical device used primarily in uterine fibroid embolization procedures. It is utilized by interventional radiologists and gynecologists to facilitate access and delivery of embolic agents.
FDA Clearance Information
Pathway
510K
Number
K972599 ↗
Decision Date
September 19, 1997
Product Code
HWC
Device Class
Class 2
Evidence
0 studies
The Acufex Screw Cannula was cleared through the FDA's 510(k) pathway on September 19, 1997. Manufactured by Smith & Nephew Endoscopy, it is classified as a Class 2 device under product code HWC.
What It Is
The Acufex Screw Cannula is a specialized medical instrument designed to aid in minimally invasive procedures. It features a screw mechanism that allows for secure placement and stabilization within the body, facilitating the delivery of therapeutic agents. This device is particularly useful in procedures requiring precise access and control, such as embolization.
Clinical Applications
Commonly used in uterine fibroid embolization, the Acufex Screw Cannula is employed by interventional radiologists to deliver embolic agents to uterine arteries, reducing fibroid size and symptoms. It is typically used in hospital settings or specialized outpatient centers. The device is suitable for adult female patients experiencing symptomatic uterine fibroids.
Indications for Use
The FDA-cleared indication for the Acufex Screw Cannula is its use in uterine fibroid embolization procedures. This involves treating women with symptomatic uterine fibroids by reducing their blood supply, thereby alleviating symptoms like heavy menstrual bleeding and pelvic pain.
Practical Considerations
The Acufex Screw Cannula comes in various sizes to accommodate different anatomical requirements and procedural needs. It is compatible with standard embolization techniques and should be used by trained professionals familiar with vascular access and embolization procedures.
Frequently Asked Questions
What is the Acufex Screw Cannula used for?
It is used in uterine fibroid embolization procedures to deliver embolic agents to uterine arteries.
What specialties typically use this device?
Interventional radiologists and gynecologists commonly use this device.
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.