Prismaflex System 8.10

Prismaflex System 8.10 is an FDA 510(k)-cleared medical device (K171671) manufactured by Baxter Healthcare 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 February 22, 2018. Regulation: 8.