UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER

UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER is an FDA 510(k)-cleared medical device (K003580) manufactured by Unisensor AG. 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 July 30, 2001. Regulation: 8.