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acufex suture retriever
Acufex Microsurgical
Summary: The Acufex Suture Retriever is a surgical tool used primarily in minimally invasive procedures to retrieve sutures. It is commonly utilized by orthopedic surgeons in arthroscopic surgeries.
FDA Clearance Information
Pathway
510K
Number
K926036 ↗
Decision Date
May 5, 1993
Product Code
GAE
Device Class
Class 1
Evidence
0 studies
The Acufex Suture Retriever was cleared through the FDA 510(k) pathway on May 5, 1993, by Acufex Microsurgical. It is classified as a Class 1 device under product code GAE.
What It Is
The Acufex Suture Retriever is a specialized surgical instrument designed to grasp and retrieve sutures during minimally invasive procedures. It features a slender, elongated design that allows for precise maneuvering within small surgical sites. This device is particularly useful in arthroscopic surgeries, where it aids in the management of sutures within joint spaces.
Clinical Applications
The Acufex Suture Retriever is commonly used in orthopedic surgeries, particularly arthroscopy, to manage sutures in joint repair procedures. It is essential in settings such as sports medicine clinics and hospitals where minimally invasive techniques are preferred. The device is suitable for use in procedures involving the knee, shoulder, and other joints, facilitating efficient suture management in complex surgical environments.
Indications for Use
The FDA-cleared indications for the Acufex Suture Retriever involve its use in procedures requiring the retrieval of sutures, typically in minimally invasive surgeries. It is designed for patients undergoing arthroscopic procedures where precise suture handling is necessary.
Practical Considerations
The Acufex Suture Retriever is available in various sizes to accommodate different surgical needs and is compatible with standard arthroscopic equipment. Surgeons should be familiar with its handling and ensure compatibility with other instruments used during procedures.
Frequently Asked Questions
What is Acufex Suture Retriever used for?
The Acufex Suture Retriever is used to grasp and retrieve sutures during minimally invasive surgeries, particularly in arthroscopy.
What specialties typically use this device?
Orthopedic surgeons, especially those specializing in sports medicine and arthroscopic procedures, typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring suture retrieval, especially in minimally invasive surgeries like arthroscopy.
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.