Tissue Removal Pouch

Tissue Removal Pouch is an FDA 510(k)-cleared medical device (K150781) manufactured by Boehringer Laboratories, LLC. 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 18, 2015. Regulation: 8.