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acufex magnetic retriever
Acufex Microsurgical
Summary: The Acufex Magnetic Retriever is a surgical instrument used primarily in procedures involving the retrieval of metallic objects from the body. It is typically used by surgeons in operating room settings.
FDA Clearance Information
Pathway
510K
Number
K822439 ↗
Decision Date
October 13, 1982
Product Code
—
Device Class
—
Evidence
0 studies
The Acufex Magnetic Retriever was cleared through the FDA 510k pathway on October 13, 1982. Manufactured by Acufex Microsurgical, it is not classified under a specific device class or product code.
What It Is
The Acufex Magnetic Retriever is a specialized surgical tool designed to retrieve metallic objects from within the body. It utilizes magnetic force to attract and secure metal fragments or devices during surgical procedures. This tool is particularly useful in scenarios where precision and control are required to safely remove foreign metallic bodies.
Clinical Applications
This device is commonly used in surgical settings, particularly in orthopedic and general surgery, where metallic objects such as screws or fragments need to be retrieved. It is also applicable in emergency medicine for the removal of ingested or embedded metallic foreign bodies. The device is suitable for use in both adult and pediatric populations, depending on the clinical scenario.
Indications for Use
The FDA indications suggest its use in procedures requiring the retrieval of metallic objects from the body. This includes situations such as retrieving surgical instruments or fragments that have become lodged within the body during a procedure.
Practical Considerations
The Acufex Magnetic Retriever is typically available in various sizes to accommodate different surgical needs. It is important to ensure compatibility with other surgical instruments and to be aware of the magnetic strength to avoid unintended attraction of nearby metallic objects.
Frequently Asked Questions
What is Acufex Magnetic Retriever used for?
It is used for retrieving metallic objects from the body during surgical procedures.
What specialties typically use this device?
Orthopedic surgeons, general surgeons, and emergency medicine specialists commonly use this device.
What are the FDA-cleared indications?
It is indicated for the retrieval of metallic objects from the body, such as surgical instruments or fragments.
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.