HI-Q HAND INSTRUMENTS- UROLOGY

HI-Q HAND INSTRUMENTS- UROLOGY is an FDA 510(k)-cleared medical device (K944201) manufactured by Olympus America, 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 28, 1994. Regulation: 8.