510(k) K231249

PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL by Pentax of America, Inc. — Product Code PEA

K231249 is an FDA 510(k) premarket notification submitted by Pentax of America, Inc. for the device "PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL". The FDA issued a decision of Substantially Equivalent on July 28, 2023. The device falls under product code PEA (Endoscope, Accessories, Image Post-Processing For Color Enhancement), a Class II device regulated under 21 CFR 876.1500. Pentax of America, Inc. has at least 10 other 510(k) clearances on record.