FLEXIFLO SACKS-VINE GASTROSTOMY KITS

FLEXIFLO SACKS-VINE GASTROSTOMY KITS is an FDA 510(k)-cleared medical device (K910332) 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 March 18, 1991. Regulation: 8.