SYN-OPTICS #5200

SYN-OPTICS #5200 is an FDA 510(k)-cleared medical device (K820624) manufactured by Syn-Optics. 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 March 31, 1982. Regulation: 8.