510(k) K252617

MiroCam® Capsule Endoscope System by Intromedic Co., Ltd. — Product Code NEZ

K252617 is an FDA 510(k) premarket notification submitted by Intromedic Co., Ltd. for the device "MiroCam® Capsule Endoscope System". The FDA issued a decision of Substantially Equivalent on May 8, 2026. The device falls under product code NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule), a Class II device regulated under 21 CFR 876.1300. Intromedic Co., Ltd. has at least 10 other 510(k) clearances on record.