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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 ?
510(k)
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.
FDA-Cleared Indications
- For grasping, holding, and manipulating tissue during surgical procedures.
- For use by trained surgical personnel when a forceps instrument is appropriate for the procedure.
Clinical Applications
- Tissue handling during open surgical procedures.
- Tissue manipulation during minimally invasive or endoscopic procedures when the specific instrument configuration is suitable.
- Grasping or holding tissue to support dissection, exposure, repair, or removal.
Practical Considerations
- Available sizes, jaw configurations, and shaft lengths may vary; the exact model should be selected for the anatomy and surgical approach.
- Use requires appropriate surgical training and familiarity with the instrument's jaw mechanics and intended handling technique.
- The device should be inspected, cleaned, sterilized, and maintained according to the manufacturer's instructions if it is a reusable instrument.
- The FDA record does not establish MRI safety. MRI use should be avoided unless the specific instrument is labeled MRI safe or MRI conditional.
- Contraindications and precautions depend on the specific model, procedure, tissue condition, and applicable manufacturer labeling.
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.