SDC3 HD Information Management System with Wireless Device Control Capability

SDC3 HD Information Management System with Wireless Device Control Capability is an FDA 510(k)-cleared medical device (K210584) manufactured by Stryker. 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 March 17, 2021. Regulation: 8.