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acufex arthroscopic shaver
Acufex Microsurgical
Summary: The Acufex Arthroscopic Shaver is a surgical tool used primarily in minimally invasive procedures to remove tissue. It is commonly used by orthopedic surgeons during arthroscopic surgeries.
FDA Clearance Information
Pathway
510K
Number
K844130 ↗
Decision Date
March 21, 1985
Product Code
HSZ
Device Class
Class 1
Evidence
0 studies
The Acufex Arthroscopic Shaver was cleared through the FDA 510(k) pathway on March 21, 1985. It is manufactured by Acufex Microsurgical and is classified as a Class 1 device under product code HSZ.
What It Is
The Acufex Arthroscopic Shaver is a precision surgical instrument designed for use in arthroscopic procedures. It consists of a motorized handpiece with interchangeable blades that allow for the resection of soft tissue and bone. This device enhances the surgeon's ability to perform minimally invasive surgeries by providing efficient tissue removal and debridement.
Clinical Applications
This device is commonly used in orthopedic surgeries, particularly for knee and shoulder arthroscopy. It assists in procedures such as meniscectomies, synovectomies, and the removal of loose bodies. The shaver is essential in sports medicine and orthopedic settings, catering to patients with joint issues requiring minimally invasive intervention.
Indications for Use
The Acufex Arthroscopic Shaver is indicated for use in procedures requiring the removal of soft tissue and bone during arthroscopy. It is suitable for patients undergoing joint surgeries, particularly in the knee and shoulder, to address conditions like torn meniscus or damaged cartilage.
Practical Considerations
The device typically comes with various blade sizes and configurations to suit different surgical needs. It is compatible with standard arthroscopic equipment and requires careful handling to avoid damage to surrounding tissues. Surgeons should be familiar with its operation to maximize efficiency and safety during procedures.
Frequently Asked Questions
What is the Acufex Arthroscopic Shaver used for?
It is used for the removal of soft tissue and bone during arthroscopic surgeries, particularly in the knee and shoulder.
What specialties typically use this device?
Orthopedic surgeons and sports medicine specialists commonly use this device in arthroscopic procedures.
What are the FDA-cleared indications?
It is indicated for use in arthroscopic procedures requiring tissue and bone removal, such as meniscectomies and synovectomies.
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.