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 ?
510(k)
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.
FDA-Cleared Indications
- Surgical treatment of carpal tunnel syndrome.
Clinical Applications
- Arthroscopic release of the transverse carpal ligament.
- Treatment of median nerve compression within the carpal tunnel.
- Use during minimally invasive carpal tunnel release procedures in hospitals or outpatient surgical facilities.
Practical Considerations
- The kit is intended for use by surgeons trained in arthroscopic and carpal tunnel release techniques.
- The instruments are used with visualization equipment and compatible arthroscopic surgical equipment.
- Careful patient selection and preoperative assessment are needed to evaluate the diagnosis, anatomy, and suitability for an arthroscopic approach.
- The kit is a surgical instrument set, not an implant; it does not remain in the body after the procedure.
- MRI safety depends on the specific instrument materials and whether any component is present in or near the scanner. The manufacturer's labeling should be reviewed, and instruments should not be taken into an MRI environment unless their status is confirmed.
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.