đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- The FDA indication cannot be stated reliably from the supplied record because the FDA indications field contains only “Summary.”
- Use should be limited to the indication, patient population, anatomical site, and procedural instructions in the device’s official labeling.
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.
Practical Considerations
- Confirm the current manufacturer labeling, catalog number, dimensions, and intended procedure before use; the supplied record does not list device sizes or technical specifications.
- Use by trained clinicians familiar with cannula placement, sterile technique, vascular or procedural access, and management of bleeding or other access-related complications.
- Do not assume MRI safety. MRI conditions, if any, must be verified in the current labeling or with the manufacturer.
- Confirm compatibility with the intended guidewires, catheters, delivery systems, embolic materials, and imaging equipment before the procedure.
- Potential risks depend on the access route and procedure and may include bleeding, infection, tissue or vessel injury, malposition, thrombosis, and device breakage or retention.
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.