đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Used to retrieve sutures during surgical procedures when suture capture or removal is required.
- Intended for use as a surgical instrument in minimally invasive procedures, including arthroscopic procedures, according to the device labeling.
Clinical Applications
- Retrieving or grasping sutures during arthroscopic surgery.
- Managing sutures during minimally invasive repair procedures involving a joint.
- Suture handling during orthopedic procedures involving the knee, shoulder, or other joints when the instrument is appropriate for the procedure.
Practical Considerations
- The device is a manual surgical instrument; the surgeon controls its advancement, grasping, and withdrawal.
- Available size and configuration should be selected for the operative site and the suture being retrieved.
- Confirm compatibility with the arthroscope, cannula, and other instruments used for the procedure.
- Use requires familiarity with arthroscopic visualization and instrument handling to avoid unintended tissue or suture damage.
- MRI safety information is not established in the supplied FDA record; consult the current manufacturer labeling before MRI exposure.
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.