
Pentax of America, Inc.
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PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family is an FDA 510(k)-cleared medical device (K191282) manufactured by Pentax of 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 7, 2019. Regulation: 8.