About This 510(k) Submission
K150618 is an FDA 510(k) clearance for the PENTAX Medical EPK-i7010 Video Processor with GI Family, a Endoscope, Accessories, Image Post-processing For Color Enhancement (Class II — Special Controls, product code PEA), submitted by Pentax of America, Inc. (Montvale, US). The FDA issued a Cleared decision on November 24, 2015, 259 days after receiving the submission on March 10, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.