
Pentax Medical
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PENTAX Medical ED-3490TK Video Duodenoscope is an FDA 510(k)-cleared medical device (K192280) manufactured by Pentax Medical. 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 October 20, 2019. Regulation: 8.