510(k) K183053

Olympus Small Intestinal Capsule Endoscope System by Olympus Medical Systems Corp. — Product Code NEZ

K183053 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "Olympus Small Intestinal Capsule Endoscope System". The FDA issued a decision of Substantially Equivalent on March 5, 2019. The device falls under product code NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule), a Class II device regulated under 21 CFR 876.1300. Olympus Medical Systems Corp. has at least 10 other 510(k) clearances on record.