DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE

DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE is an FDA 510(k)-cleared medical device (K000646) manufactured by Enteric Medical Technologies. 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 12, 2000. Regulation: 8.