H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005

H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005 is an FDA 510(k)-cleared medical device (K013972) manufactured by Ackard Laboratories. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 16, 2001. Regulation: 8.