FLEX-NECK ARC CATHETER

FLEX-NECK ARC CATHETER is an FDA 510(k)-cleared medical device (K070730) manufactured by Medigroup, 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 July 2, 2007. Regulation: 8.