Seal Single Use Biopsy Valve

Seal Single Use Biopsy Valve is an FDA 510(k)-cleared medical device (K182275) manufactured by Boston Scientific Corporation. 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 September 12, 2018. Regulation: 8.