Orca Air/Water and Suction Valves

Orca Air/Water and Suction Valves is an FDA 510(k)-cleared medical device (K252910) manufactured by Boston Scientific. 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 October 8, 2025. Regulation: 8.