GELBFISH ENDO-VAC SYSTEM

GELBFISH ENDO-VAC SYSTEM is an FDA 510(k)-cleared medical device (K970233) manufactured by Gary A. Gelbfish. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 7, 1997. Regulation: 8.