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acufex double armed suture needle
Smith & Nephew Endoscopy
Summary: The Acufex Double Armed Suture Needle is a surgical tool used primarily in minimally invasive procedures to suture tissues. It is commonly used by orthopedic surgeons and other specialists performing arthroscopic surgeries.
FDA Clearance Information
Pathway
510K
Number
K970416 ↗
Decision Date
April 21, 1997
Product Code
GAT
Device Class
Class 2
Evidence
0 studies
The Acufex Double Armed Suture Needle was cleared through the FDA 510(k) pathway on April 21, 1997. Manufactured by Smith & Nephew Endoscopy, it is classified as a Class 2 medical device.
What It Is
The Acufex Double Armed Suture Needle is a specialized surgical instrument designed for use in minimally invasive procedures. It features two needles attached to a single suture, allowing for efficient and precise tissue approximation. This device is particularly useful in arthroscopic surgeries where access is limited and precision is crucial.
Clinical Applications
This device is commonly used in orthopedic surgeries, particularly arthroscopic procedures such as rotator cuff repairs and meniscal suturing. It is also applicable in other minimally invasive surgeries where suturing is required. The device is typically used in hospital operating rooms and outpatient surgical centers by orthopedic surgeons and other specialists trained in minimally invasive techniques.
Indications for Use
The FDA indications for the Acufex Double Armed Suture Needle include its use in procedures requiring tissue suturing, particularly in minimally invasive surgeries. It is suitable for patients undergoing arthroscopic procedures or other surgeries where precise suturing is necessary.
Practical Considerations
The Acufex Double Armed Suture Needle is available in various sizes to accommodate different surgical needs. It is compatible with standard arthroscopic equipment and requires familiarity with minimally invasive suturing techniques. Proper handling and technique are essential to ensure optimal outcomes.
Frequently Asked Questions
What is the Acufex Double Armed Suture Needle used for?
It is used for suturing tissues in minimally invasive surgeries, particularly in orthopedic procedures like arthroscopy.
What specialties typically use this device?
Orthopedic surgeons and other specialists performing minimally invasive procedures commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring tissue suturing, especially in minimally invasive 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.