510(k) K161773

CapsoCam Plus (SV-3) Capsule Endoscope System by CapsoVision, Inc. — Product Code NEZ

K161773 is an FDA 510(k) premarket notification submitted by CapsoVision, Inc. for the device "CapsoCam Plus (SV-3) Capsule Endoscope System". The FDA issued a decision of Substantially Equivalent on October 21, 2016. The device falls under product code NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule), a Class II device regulated under 21 CFR 876.1300. CapsoVision, Inc. has at least 5 other 510(k) clearances on record.