7 mm Extended Length Endoscope

7 mm Extended Length Endoscope is an FDA 510(k)-cleared medical device (K191930) manufactured by Maquet Cardiovascular, LLC. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 14, 2020. Regulation: 8.