SENTRY EXPANDING INTRODUCER SHEATH (EIS)

SENTRY EXPANDING INTRODUCER SHEATH (EIS) is an FDA 510(k)-cleared medical device (K000545) manufactured by Applied Medical Resources. 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 May 1, 2000. Regulation: 8.