STRYKER INFRAVISION ESOPHAGEAL KIT

STRYKER INFRAVISION ESOPHAGEAL KIT is an FDA 510(k)-cleared medical device (K983220) manufactured by Stryker Endoscopy. 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 June 3, 1999. Regulation: 8.