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acufex disposable meniscal cannula
Acufex Microsurgical
Summary: The Acufex Disposable Meniscal Cannula is a surgical tool used primarily in orthopedic procedures involving the meniscus. It is utilized by orthopedic surgeons to assist in meniscal repair and related procedures.
FDA Clearance Information
Pathway
510K
Number
K932090 ↗
Decision Date
June 28, 1994
Product Code
HRX
Device Class
Class 2
Evidence
0 studies
The Acufex Disposable Meniscal Cannula was cleared through the FDA 510(k) pathway on June 28, 1994. It is manufactured by Acufex Microsurgical and classified as a Class 2 medical device.
What It Is
The Acufex Disposable Meniscal Cannula is a surgical instrument designed for use in arthroscopic procedures, particularly those involving the meniscus of the knee. It facilitates the delivery of surgical instruments or materials to the meniscal area, aiding in repair or removal procedures. Its disposable nature ensures sterility and reduces the risk of cross-contamination between patients.
Clinical Applications
This device is commonly used in orthopedic and sports medicine settings, particularly during arthroscopic knee surgeries. It is essential for procedures involving meniscal tears, allowing surgeons to access and treat the affected area with precision. The device is typically used in hospitals and outpatient surgical centers, catering to patients with knee injuries, often athletes or individuals with degenerative joint conditions.
Indications for Use
The FDA indications suggest that the device is intended for use in procedures involving the meniscus. Clinically, it is used for patients experiencing meniscal tears or damage, often due to sports injuries or degenerative conditions.
Practical Considerations
The Acufex Disposable Meniscal Cannula is available in various sizes to accommodate different patient anatomies and surgical needs. It is compatible with standard arthroscopic equipment and requires careful handling to ensure precise delivery of surgical tools or materials.
Frequently Asked Questions
What is the Acufex Disposable Meniscal Cannula used for?
It is used in arthroscopic knee surgeries to assist in the repair or removal of the meniscus.
What specialties typically use this device?
Orthopedic surgeons and sports medicine specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the meniscus, such as repairs and treatments of meniscal tears.
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.