CYSTOGLIDE DILATING INTRODUCER SHEATH

CYSTOGLIDE DILATING INTRODUCER SHEATH is an FDA 510(k)-cleared medical device (K052134) manufactured by Percutaneous Systems, Inc.. 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 September 21, 2005. Regulation: 8.