FLEXIFLO OVER-THE-GUIDEWIRE GAST KIT W/CR-BAR BUMP

FLEXIFLO OVER-THE-GUIDEWIRE GAST KIT W/CR-BAR BUMP is an FDA 510(k)-cleared medical device (K913786) manufactured by Abbott Laboratories. 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 November 4, 1991. Regulation: 8.