GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG

GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG is an FDA 510(k)-cleared medical device (K132375) manufactured by Genicon. 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 June 11, 2014. Regulation: 8.