CYSTOGLIDE INTRODUCER SHEATH

CYSTOGLIDE INTRODUCER SHEATH is an FDA 510(k)-cleared medical device (K052298) manufactured by Percutaneous Systems, Incorporated. 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 December 11, 2006. Regulation: 8.