đź“‹ FDA Reference
acufex arthroscopic carpal tunnel release kit
Acufex Microsurgical
Summary: The Acufex Arthroscopic Carpal Tunnel Release Kit is a surgical tool used for minimally invasive carpal tunnel release procedures. It is typically utilized by orthopedic and hand surgeons to relieve pressure on the median nerve.
FDA Clearance Information
Pathway
510K
Number
K922557 ↗
Decision Date
September 17, 1992
Product Code
HRX
Device Class
Class 2
Evidence
0 studies
The Acufex Arthroscopic Carpal Tunnel Release Kit was cleared through the FDA 510(k) pathway on September 17, 1992. Manufactured by Acufex Microsurgical, it is classified as a Class 2 device under product code HRX.
What It Is
The Acufex Arthroscopic Carpal Tunnel Release Kit is a specialized surgical instrument set designed for performing carpal tunnel release via an arthroscopic approach. This minimally invasive technique involves using an endoscope to visualize the carpal tunnel and a cutting tool to release the transverse carpal ligament, thereby alleviating pressure on the median nerve. This approach can potentially reduce recovery time and postoperative complications compared to open surgery.
Clinical Applications
This device is primarily used in orthopedic and hand surgery settings to treat carpal tunnel syndrome, a condition characterized by numbness, tingling, and weakness in the hand due to median nerve compression. It is suitable for use in outpatient surgery centers and hospitals, particularly for patients who are candidates for minimally invasive procedures. The kit is designed to facilitate precise ligament release while minimizing tissue disruption.
Indications for Use
The FDA-cleared indication for this device is for the surgical treatment of carpal tunnel syndrome. It is intended for patients experiencing symptoms such as hand pain, numbness, or weakness due to compression of the median nerve within the carpal tunnel.
Practical Considerations
When using the Acufex Arthroscopic Carpal Tunnel Release Kit, surgeons should be familiar with arthroscopic techniques and have experience in carpal tunnel procedures. The kit is compatible with standard arthroscopic equipment and requires careful handling to ensure precise ligament release. Proper patient selection and preoperative planning are crucial for optimal outcomes.
Frequently Asked Questions
What is the Acufex Arthroscopic Carpal Tunnel Release Kit used for?
It is used for performing minimally invasive carpal tunnel release procedures to alleviate symptoms of carpal tunnel syndrome.
What specialties typically use this device?
Orthopedic and hand surgeons commonly use this device in surgical settings.
What are the FDA-cleared indications?
The device is indicated for the surgical treatment of carpal tunnel syndrome, specifically for releasing the transverse carpal ligament to relieve median nerve compression.
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.