đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- The FDA record identifies Acufex Sterile Drills as surgical drilling instruments under product code HWE.
- The available FDA indications text is listed only as "Statement"; specific cleared procedures or anatomical uses cannot be confirmed from the supplied record.
Clinical Applications
- Use as a sterile surgical drilling instrument when selected for a procedure covered by the manufacturer's labeling.
- Use with a compatible surgical drill system according to the device instructions for use.
- Use by trained surgical personnel in an operating room or other controlled surgical setting.
Practical Considerations
- The supplied record does not document the available drill diameters, lengths, cutting configurations, or compatible handpieces; confirm these details in the current manufacturer's labeling.
- Sterility, packaging integrity, and expiration date should be checked before use. A device labeled sterile and single-use should not be resterilized or reused unless the labeling specifically permits it.
- MRI safety cannot be determined from the supplied FDA record. Do not bring the drill or its packaging into the MRI environment without reviewing the manufacturer's MRI labeling.
- Use requires appropriate surgical training and a compatible powered or manual drill system. Follow the manufacturer's instructions for speed, irrigation, loading, and removal.
- Potential contraindications and precautions depend on the specific procedure, tissue being drilled, patient anatomy, infection risk, and the device's current instructions for 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.