đź“‹ FDA Reference
acufex video system
Acufex Microsurgical
Summary: The Acufex Video System is a medical imaging device used primarily in surgical procedures to provide visual guidance. It is utilized by surgeons, particularly in gynecological procedures such as uterine fibroid embolization.
FDA Clearance Information
Pathway
510K
Number
K940241 ↗
Decision Date
April 12, 1994
Product Code
GCJ
Device Class
Class 2
Evidence
0 studies
The Acufex Video System was cleared through the FDA 510(k) pathway on April 12, 1994. Manufactured by Acufex Microsurgical, it is classified as a Class 2 device under product code GCJ.
What It Is
The Acufex Video System is a surgical video imaging device designed to enhance visualization during minimally invasive procedures. It consists of a camera and display system that provides real-time video feedback to the surgeon. This device aids in precision and accuracy during surgical interventions, particularly in complex anatomical areas.
Clinical Applications
The Acufex Video System is commonly used in gynecological surgeries, such as uterine fibroid embolization, where clear visualization of the surgical field is crucial. It is also applicable in other minimally invasive procedures across various specialties, including orthopedics and general surgery. The device is typically used in hospital operating rooms and outpatient surgical centers.
Indications for Use
The FDA-cleared indication for the Acufex Video System is for use in procedures requiring enhanced visualization, such as uterine fibroid embolization. It is intended for patients undergoing minimally invasive surgical interventions where visual guidance is necessary.
Practical Considerations
The Acufex Video System is compatible with standard surgical instruments and is designed to integrate seamlessly into existing operating room setups. Surgeons should be familiar with video-assisted surgical techniques to optimize the use of this device. Regular maintenance and calibration are recommended to ensure optimal performance.
Frequently Asked Questions
What is Acufex Video System used for?
The Acufex Video System is used for providing enhanced visualization during surgical procedures, particularly in minimally invasive surgeries such as uterine fibroid embolization.
What specialties typically use this device?
This device is typically used by gynecologists, orthopedic surgeons, and general surgeons in minimally invasive procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring enhanced visualization, such as uterine fibroid embolization, to assist in surgical precision and accuracy.
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.