OSTAVI HYDROPHILIC GUIDEWIRE

OSTAVI HYDROPHILIC GUIDEWIRE is an FDA 510(k)-cleared medical device (K124052) manufactured by Lake Region Medical. 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 25, 2013. Regulation: 8.