ENDOSCOPIC SCLEROTHERAPY BALLOON

ENDOSCOPIC SCLEROTHERAPY BALLOON is an FDA 510(k)-cleared medical device (K821999) manufactured by Retech. 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 August 26, 1982. Regulation: 8.