GUIDE-TECH ENCAPSULATED GUIDEWIRE

GUIDE-TECH ENCAPSULATED GUIDEWIRE is an FDA 510(k)-cleared medical device (K926039) manufactured by Cape Tech Medical Products. 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 August 4, 1993. Regulation: 8.