RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR

RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR is an FDA 510(k)-cleared medical device (K050232) manufactured by Boston Scientific Corp. 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 March 10, 2005. Regulation: 8.