REPROCESSED TROCARS, MODEL B5LT AND CB5LT

REPROCESSED TROCARS, MODEL B5LT AND CB5LT is an FDA 510(k)-cleared medical device (K100080) manufactured by Ascent Healthcare Solutions. 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 18, 2010. Regulation: 8.