SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE

SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE is an FDA 510(k)-cleared medical device (K080050) manufactured by Spirus Medical, Inc.. 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 May 5, 2008. Regulation: 8.