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acufex linear rotary instruments
Acufex Microsurgical
Summary: Acufex Linear Rotary Instruments are surgical tools used primarily in procedures involving uterine fibroid embolization. They are typically utilized by gynecologists and interventional radiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K940981 ↗
Decision Date
May 16, 1994
Product Code
HRX
Device Class
Class 2
Evidence
0 studies
The Acufex Linear Rotary Instruments were cleared through the FDA 510k pathway on May 16, 1994. Manufactured by Acufex Microsurgical, this device is classified as Class 2 under product code HRX.
What It Is
The Acufex Linear Rotary Instruments are precision surgical tools designed for use in minimally invasive procedures. They feature a linear rotary mechanism that allows for precise control and manipulation during surgery. These instruments are particularly useful in procedures requiring fine motor skills and accuracy, such as uterine fibroid embolization.
Clinical Applications
These instruments are commonly used in gynecological procedures, particularly in the treatment of uterine fibroids through embolization. They are employed by specialists such as gynecologists and interventional radiologists in hospital operating rooms and specialized surgical centers. The device is suitable for adult female patients experiencing symptoms related to uterine fibroids.
Indications for Use
The FDA has cleared these instruments for use in procedures like uterine fibroid embolization, which is a minimally invasive treatment for symptomatic uterine fibroids. This procedure is typically indicated for women who experience heavy menstrual bleeding, pelvic pain, or other fibroid-related symptoms.
Practical Considerations
These instruments are available in various sizes to accommodate different surgical needs and patient anatomies. They are compatible with standard surgical setups and require careful handling to maintain their precision. Proper sterilization and maintenance are essential for optimal performance.
Frequently Asked Questions
What is Acufex Linear Rotary Instruments used for?
They are used for surgical procedures, particularly uterine fibroid embolization, to treat symptomatic uterine fibroids.
What specialties typically use this device?
Gynecologists and interventional radiologists commonly use these instruments in their practice.
What are the FDA-cleared indications?
The device is cleared for use in procedures like uterine fibroid embolization, aimed at treating symptomatic 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.