FUJIFILM Stiffening Wire Device (SW-2000)

FUJIFILM Stiffening Wire Device (SW-2000) is an FDA 510(k)-cleared medical device (K251204) manufactured by FUJIFILM Healthcare Americas Corporation. 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 25, 2025. Regulation: 8.