OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR

OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR is an FDA 510(k)-cleared medical device (K031147) 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 January 11, 2004. Regulation: 8.