510(k) K163495

AdvanCE capsule endoscope delivery device by United States Endoscopy Group, Inc. — Product Code NEZ

K163495 is an FDA 510(k) premarket notification submitted by United States Endoscopy Group, Inc. for the device "AdvanCE capsule endoscope delivery device". The FDA issued a decision of Substantially Equivalent on March 10, 2017. The device falls under product code NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule), a Class II device regulated under 21 CFR 876.1300. United States Endoscopy Group, Inc. has at least 10 other 510(k) clearances on record.