đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- The FDA record lists the indication as "Statement" under product code HRX.
- The available record does not include the complete FDA-cleared indication statement.
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.
Practical Considerations
- Review the complete FDA 510(k) summary, device labeling, and instructions for use before clinical use.
- Confirm the device identity, intended procedure, size, and compatibility with other instruments or embolization equipment.
- Do not assume MRI safety; MRI compatibility must be verified in the manufacturer’s labeling.
- Use only according to the manufacturer’s instructions and institutional policies.
- The available record does not provide validated dimensions, materials, shelf life, sterilization information, or contraindications.
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.