Issue Date: October 30, 2017
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k), Labeling, Safety – Issues, Errors, and Problems, Obstetrical & Gynecological, General & Plastic Surgery
Status: Final
Product Labeling for Certain Ultrasonic Surgical Aspirator Devices: Guidance for Industry and Food and Drug Administration Staff
The Food and Drug Administration (FDA) is issuing this guidance to recommend the addition of a specific safety statement to the product labeling of certain ultrasonic surgical aspirator devices. Ultrasonic surgical aspirator devices are surgical tools intended to fragment, emulsify and aspirate hard and soft tissue. These devices can be used in many different surgical specialties for a wide range of procedures, including the debulking of malignant tumors. Ultrasonic surgical aspirators cause tissue fragmentation through the delivery of ultrasound energy to target tissue through an oscillating tip. Tissue fragments are aspirated through the inner lumen of the device. This mechanism of action creates the potential for tissue dissemination. The incorporation of suction/aspiration reduces but cannot eliminate this potential. In light of the risk of tissue dissemination from use of these devices, the FDA is providing a specific labeling recommendation in this guidance to promote the safe and effective use of ultrasonic surgical aspirator devices.
Download the Guidance Document
