MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM

MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM is an FDA 510(k)-cleared medical device (K030315) manufactured by Ultroid, 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 February 26, 2003. Regulation: 8.