
M.E.R. Surgical Co.
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M.E.R. SURGICAL CO. OMNI INSTRUMENT SYSTEM is an FDA 510(k)-cleared medical device (K944309) manufactured by M.E.R. Surgical Co.. 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 2, 1995. Regulation: 8.