510(k) K180583

LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD by Richard Wolf Medical Instruments Corporation — Product Code FET

K180583 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corporation for the device "LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD". The FDA issued a decision of Substantially Equivalent on June 28, 2018. The device falls under product code FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Richard Wolf Medical Instruments Corporation has at least 10 other 510(k) clearances on record.