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acufex sterile drills
Acufex Microsurgical
Summary: Acufex Sterile Drills are surgical tools used primarily in orthopedic and gynecological procedures. They are designed for precision drilling in surgical settings, typically used by surgeons specializing in these areas.
FDA Clearance Information
Pathway
510K
Number
K931837 ↗
Decision Date
January 7, 1994
Product Code
HWE
Device Class
Class 1
Evidence
0 studies
The Acufex Sterile Drills were cleared through the FDA 510(k) pathway on January 7, 1994. Manufactured by Acufex Microsurgical, this device is classified as a Class 1 medical device.
What It Is
The Acufex Sterile Drills are precision surgical instruments designed for drilling into bone or other hard tissues. They are typically used in minimally invasive procedures, offering high accuracy and control. These drills are sterile, single-use devices, ensuring safety and reducing the risk of infection during surgical procedures.
Clinical Applications
These drills are commonly used in orthopedic surgeries, such as arthroscopic procedures, where precision drilling is required. They are also used in gynecological procedures like uterine fibroid embolization, where access to specific anatomical sites is necessary. Surgeons in hospital operating rooms or specialized surgical centers frequently use these devices.
Indications for Use
The FDA indications suggest that Acufex Sterile Drills are intended for procedures requiring precise drilling, particularly in orthopedic and gynecological contexts. They are suitable for patients undergoing surgeries that involve bone or hard tissue manipulation.
Practical Considerations
Acufex Sterile Drills come in various sizes to accommodate different surgical needs. They are compatible with standard surgical drill systems and require careful handling to maintain sterility. Surgeons should be familiar with the specific technique required for optimal use.
Frequently Asked Questions
What is Acufex Sterile Drills used for?
Acufex Sterile Drills are used for precision drilling in orthopedic and gynecological surgeries.
What specialties typically use this device?
Orthopedic surgeons and gynecologists typically use this device in surgical settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring precise drilling, such as orthopedic surgeries and uterine fibroid embolization.
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.