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acufex arthroscopic suture cutter
Acufex Microsurgical
Summary: The Acufex Arthroscopic Suture Cutter is a surgical tool used primarily by orthopedic surgeons for cutting sutures during arthroscopic procedures. It is designed for precision and ease of use in minimally invasive surgeries.
FDA Clearance Information
Pathway
510K
Number
K940506 ↗
Decision Date
April 26, 1994
Product Code
HRX
Device Class
Class 2
Evidence
0 studies
The Acufex Arthroscopic Suture Cutter was cleared via the FDA 510(k) pathway on April 26, 1994. Manufactured by Acufex Microsurgical, it is classified as a Class 2 device under product code HRX.
What It Is
The Acufex Arthroscopic Suture Cutter is a specialized surgical instrument designed for cutting sutures during arthroscopic procedures. It features a small, precise cutting mechanism that allows surgeons to easily and accurately cut sutures within the joint space. This device is particularly useful in minimally invasive surgeries where access is limited and precision is crucial.
Clinical Applications
This device is commonly used in orthopedic surgeries, particularly those involving the knee, shoulder, and other joints. It is employed in settings such as hospitals and outpatient surgical centers. Orthopedic surgeons and sports medicine specialists frequently use this tool when performing procedures like rotator cuff repairs or meniscus surgeries, where precise suture management is essential.
Indications for Use
The FDA-cleared indications for the Acufex Arthroscopic Suture Cutter involve its use in arthroscopic procedures requiring suture management. It is intended for patients undergoing minimally invasive joint surgeries where sutures need to be cut safely and efficiently.
Practical Considerations
The Acufex Arthroscopic Suture Cutter is typically compatible with standard arthroscopic instruments and can be used with various suture types. Surgeons should be familiar with the device's operation to ensure optimal performance and patient safety during procedures.
Frequently Asked Questions
What is the Acufex Arthroscopic Suture Cutter used for?
It is used for cutting sutures during arthroscopic procedures, particularly in orthopedic surgeries.
What specialties typically use this device?
Orthopedic surgeons and sports medicine specialists commonly use this device in joint surgeries.
What are the FDA-cleared indications?
It is indicated for use in arthroscopic procedures requiring suture management, such as minimally invasive joint surgeries.
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.