ACCU-BEAM TUBE SET

ACCU-BEAM TUBE SET is an FDA 510(k)-cleared medical device (K921208) manufactured by Tti Medical. 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 May 31, 1993. Regulation: 8.