510(k) K984168

BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE by United States Endoscopy Group, Inc. — Product Code FCF

K984168 is an FDA 510(k) premarket notification submitted by United States Endoscopy Group, Inc. for the device "BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE". The FDA issued a decision of Substantially Equivalent on December 7, 1999. The device falls under product code FCF (Instrument, Biopsy, Mechanical, Gastrointestinal), a Class II device regulated under 21 CFR 876.1075. United States Endoscopy Group, Inc. has at least 10 other 510(k) clearances on record.