ETHICON ENDO-SURGERYOPTICAL DILATOR

ETHICON ENDO-SURGERYOPTICAL DILATOR is an FDA 510(k)-cleared medical device (K093236) manufactured by Ethicon Endo-Surgery, 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 November 9, 2009. Regulation: 8.