AUTOTOME RX MODEL # 4515, 4516

AUTOTOME RX MODEL # 4515, 4516 is an FDA 510(k)-cleared medical device (K013153) manufactured by Boston Scientific Corp. 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 October 18, 2001. Regulation: 8.