DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A

DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A is an FDA 510(k)-cleared medical device (K021179) manufactured by Olympus Optical Co., Ltd.. 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 July 4, 2002. Regulation: 8.