VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)

VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) is an FDA 510(k)-cleared medical device (K973558) manufactured by Ultracell Medical Technologies, Inc.. 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 November 23, 1997. Regulation: 8.