Olympus Ultrasound Endoscope, Model number: GF-UM160 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
Worldwide distribution - US Nationwide distribution. Model Name ------------ Quantity distributed in U.S. GF-UC140P-AL5 ------------- 1,297 devices GF-UCT150-AL5 ------------- 564 devices GF-UCT180 -------------------- 3,145 devices GF-UM20 ----------------------- 31 devices GF-UM130 --------------------- 27 devices GF-UMQ130 ------------------- 373 devices GF-UM160 --------------------- 299 devices GF-UC160P-OL5 ------------- 46 devices GF-UCT160-OL5 ------------- 49 devices GF-UE160-AL5 -------------- 2,691 devices
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0504-2021