Accordion Piccolo Stone Management Device

Accordion Piccolo Stone Management Device is an FDA 510(k)-cleared medical device (K172299) manufactured by Ths International, Inc. D/B/A Accordion 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 September 18, 2017. Regulation: 8.