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 ?
510(k)
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.
FDA-Cleared Indications
- Used to provide video visualization during surgical procedures requiring visual guidance.
Clinical Applications
- Real-time visualization of the surgical field during minimally invasive procedures.
- Display of images for surgical guidance in an operating room or outpatient surgical setting.
Practical Considerations
- The record identifies the device as a video imaging system but does not specify camera dimensions, image resolution, display specifications, or compatible instruments.
- Use requires appropriate placement of the camera and display so the surgical team can view the operative field without obstructing sterile technique.
- The system should be inspected, cleaned, disinfected or sterilized as directed by its labeling, and maintained according to the manufacturer’s instructions.
- MRI compatibility is not established in the available record; do not bring the system or its components into an MRI environment unless the manufacturer has specifically labeled them as MR Safe or MR Conditional.
- The device provides visualization and does not replace clinical judgment, fluoroscopy, ultrasound, endoscopy, surgery, medication, or other treatment methods when those are required.
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.