About This 510(k) Submission
K191282 is an FDA 510(k) clearance for the PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors 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 8, 2019, 179 days after receiving the submission on May 13, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.