đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Retrieval of metallic foreign bodies from the body during a surgical procedure.
- Removal of metallic fragments or objects that are accessible to the instrument.
- Retrieval of metallic objects or fragments inadvertently retained during surgery.
Clinical Applications
- Removing accessible metallic fragments during open surgery.
- Retrieving compatible metallic objects encountered during an operative procedure.
- Removing retained metallic surgical fragments when direct access is available.
Practical Considerations
- The device should be used only for metallic objects that are sufficiently ferromagnetic to be attracted by the instrument.
- The surgeon should confirm that the object can be safely retrieved without damaging surrounding tissue or dislodging an object into a vulnerable location.
- Nearby metal instruments, implants, or equipment may also be attracted; the operative field should be controlled to prevent unintended movement.
- The available record does not specify device sizes, magnetic strength, sterilization instructions, or compatibility with particular implants.
- MRI safety should not be assumed. The instrument should be removed from the MRI environment unless the manufacturer provides specific MR safety or conditional labeling.
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.