TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021

TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021 is an FDA 510(k)-cleared medical device (K092821) manufactured by Agency For Medical Innovations, 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 31, 2010. Regulation: 8.