Capsule Surveillance System

Capsule Surveillance System is an FDA 510(k)-cleared medical device (K213335) manufactured by Capsule Surveillance Technologies, Sas /Capsule Tech, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 13, 2022. Regulation: 8.