PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KIT

PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KIT is an FDA 510(k)-cleared medical device (K923983) manufactured by Sandoz Nutrition. 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 April 5, 1993. Regulation: 8.