MediBot Needle Driver Uno

MediBot Needle Driver Uno is an FDA 510(k)-cleared medical device (K260183) manufactured by Parallel Robotics, 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 May 23, 2026. Regulation: 8.