Erbe’s CO2 Tubing/Cap Sets

Erbe’s CO2 Tubing/Cap Sets is an FDA 510(k)-cleared medical device (K162152) manufactured by Erbe USA, Inc.. 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 August 30, 2016. Regulation: 8.