510(k) K060475

EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8 by Olympus Medical Systems Corporation — Product Code ODB

K060475 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corporation for the device "EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8". The FDA issued a decision of Substantially Equivalent on March 17, 2006. The device falls under product code ODB (Endoscopic Contamination Prevention Sheath), a Class II device regulated under 21 CFR 876.1500. Olympus Medical Systems Corporation has at least 10 other 510(k) clearances on record.