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acufex forceps
Acufex Microsurgical
Summary: The Acufex Forceps are surgical instruments used primarily in orthopedic and gynecological procedures. They are utilized by surgeons for precise tissue manipulation and are especially relevant in minimally invasive surgeries.
FDA Clearance Information
Pathway
510K
Number
K800273 ↗
Decision Date
February 19, 1980
Product Code
HTD
Device Class
Class 1
Evidence
0 studies
The Acufex Forceps were cleared through the FDA 510(k) pathway on February 19, 1980. Manufactured by Acufex Microsurgical, this device is classified as a Class 1 medical device under product code HTD.
What It Is
The Acufex Forceps are precision surgical instruments designed for use in various surgical procedures. They are typically used to grasp, hold, or manipulate tissues during surgery. The design allows for fine control and accuracy, which is crucial in both open and minimally invasive surgeries.
Clinical Applications
Acufex Forceps are commonly used in orthopedic surgeries, such as ACL repairs, and in gynecological procedures like uterine fibroid embolization. They are essential in settings where precision is critical, such as in arthroscopic surgeries. Surgeons in orthopedics and gynecology frequently use these forceps to enhance surgical outcomes by minimizing tissue trauma.
Indications for Use
The FDA indications suggest that these forceps are suitable for procedures involving tissue manipulation, particularly in orthopedic and gynecological contexts. They are beneficial for patients undergoing surgeries that require precise tissue handling.
Practical Considerations
Acufex Forceps come in various sizes to accommodate different surgical needs. They are compatible with other surgical instruments used in minimally invasive procedures. Surgeons should be familiar with the specific technique required for optimal use, ensuring effective and safe outcomes.
Related Literature
The linked study explored a new surgical technique for acute patellar tendon rupture repair, highlighting the use of the Acufex ACL guide. The study found that the guide facilitated efficient and accurate placement of transosseous drill holes, reducing surgical and tourniquet time. However, the study's focus was on a specific surgical technique, and broader applications were not addressed.
Frequently Asked Questions
What is Acufex Forceps used for?
Acufex Forceps are used for tissue manipulation in surgical procedures, particularly in orthopedics and gynecology.
What specialties typically use this device?
Orthopedic surgeons and gynecologists commonly use Acufex Forceps in their procedures.
What are the FDA-cleared indications?
The FDA-cleared indications include use in procedures requiring precise tissue manipulation, such as uterine fibroid embolization and certain orthopedic surgeries.
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.