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acufex pro-pac and iso-pac
Acufex Microsurgical
Summary: The Acufex Pro-Pac and Iso-Pac are surgical devices used primarily in uterine fibroid embolization procedures. They are typically utilized by interventional radiologists and gynecologists to manage uterine fibroids.
FDA Clearance Information
Pathway
510K
Number
K931621 ↗
Decision Date
January 21, 1994
Product Code
HRX
Device Class
Class 2
Evidence
0 studies
The Acufex Pro-Pac and Iso-Pac were cleared through the FDA 510(k) pathway on January 21, 1994. Manufactured by Acufex Microsurgical, these devices are classified as Class 2 under product code HRX.
What It Is
The Acufex Pro-Pac and Iso-Pac are specialized surgical instruments designed for use in minimally invasive procedures. They are part of a suite of tools that facilitate precise surgical interventions, particularly in the context of uterine fibroid embolization. These devices are engineered to enhance the accuracy and efficiency of embolization procedures, contributing to improved patient outcomes.
Clinical Applications
These devices are commonly used in uterine fibroid embolization, a procedure performed to reduce the size and symptoms of uterine fibroids. Interventional radiologists and gynecologists often use these devices in hospital settings or specialized outpatient clinics. The typical patient population includes women experiencing symptomatic fibroids who seek a minimally invasive alternative to hysterectomy.
Indications for Use
The FDA-cleared indications for the Acufex Pro-Pac and Iso-Pac include their use in procedures aimed at managing uterine fibroids. These devices are intended for patients who require intervention to alleviate symptoms associated with fibroids, such as heavy menstrual bleeding or pelvic pain.
Practical Considerations
When using the Acufex Pro-Pac and Iso-Pac, clinicians should consider the compatibility of these devices with existing embolization equipment. Proper sizing and technique are crucial to ensure effective embolization and minimize complications. Familiarity with the device's operation can enhance procedural efficiency.
Frequently Asked Questions
What is Acufex Pro-Pac and Iso-Pac used for?
These devices are used in uterine fibroid embolization procedures to manage symptoms of uterine fibroids.
What specialties typically use this device?
Interventional radiologists and gynecologists typically use these devices.
What are the FDA-cleared indications?
The devices are indicated for use in managing uterine fibroids through 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.