đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use during surgical carpal tunnel release procedures for treatment of carpal tunnel syndrome.
Clinical Applications
- Open or minimally invasive carpal tunnel release performed by a qualified hand or orthopedic surgeon.
- Providing a pathway for compatible surgical instruments during carpal tunnel decompression.
- Helping protect adjacent tissues while the transverse carpal ligament is released.
Practical Considerations
- The listed device has a 4 mm diameter; size and compatibility should be confirmed before use.
- It is intended for use with compatible surgical instruments and the technique selected by the surgeon.
- The procedure requires knowledge of wrist and hand anatomy, including the median nerve, flexor tendons, and transverse carpal ligament.
- The FDA record identifies this as a Class II device cleared through the 510(k) pathway under product code HRX.
- MRI safety is not established by the supplied FDA record. Do not assume the device or any retained component is MRI safe; confirm the manufacturer’s current labeling.
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.