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acufex uni-cut 4 omm carpal tunnel cannula
Acufex Microsurgical
Summary: The Acufex Uni-Cut 4 mm Carpal Tunnel Cannula is a surgical tool used primarily in orthopedic procedures for carpal tunnel release. It is utilized by orthopedic surgeons and hand specialists to facilitate minimally invasive surgery.
FDA Clearance Information
Pathway
510K
Number
K942834 ↗
Decision Date
September 28, 1994
Product Code
HRX
Device Class
Class 2
Evidence
0 studies
The Acufex Uni-Cut 4 mm Carpal Tunnel Cannula was cleared through the FDA 510(k) pathway on September 28, 1994. Manufactured by Acufex Microsurgical, it is classified as a Class 2 device under product code HRX.
What It Is
The Acufex Uni-Cut 4 mm Carpal Tunnel Cannula is a specialized surgical instrument designed to aid in carpal tunnel release procedures. It features a 4 mm diameter that allows for precise cutting and tissue manipulation in the confined space of the carpal tunnel. The device is used to guide surgical tools and protect surrounding tissues during the procedure, enhancing the safety and efficacy of the surgery.
Clinical Applications
This device is commonly used in orthopedic and hand surgery settings, particularly for patients suffering from carpal tunnel syndrome. It is employed in both outpatient and inpatient surgical environments, allowing for minimally invasive techniques that reduce recovery time. The primary patient population includes adults experiencing symptoms of median nerve compression in the wrist.
Indications for Use
The FDA-cleared indication for this device is for use in carpal tunnel release procedures. It is specifically designed for patients diagnosed with carpal tunnel syndrome, a condition characterized by numbness, tingling, and weakness in the hand due to compression of the median nerve.
Practical Considerations
The Acufex Uni-Cut 4 mm Carpal Tunnel Cannula is compatible with standard surgical instruments used in carpal tunnel release. Surgeons should be familiar with the technique of minimally invasive carpal tunnel surgery to effectively utilize this device. Proper sizing and alignment are crucial to ensure optimal outcomes and minimize complications.
Frequently Asked Questions
What is the Acufex Uni-Cut 4 mm Carpal Tunnel Cannula used for?
It is used for carpal tunnel release procedures to alleviate symptoms of carpal tunnel syndrome.
What specialties typically use this device?
Orthopedic surgeons and hand specialists primarily use this device.
What are the FDA-cleared indications?
The device is indicated for use in carpal tunnel release procedures for patients with carpal tunnel syndrome.
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.