Media in the U.S. and other countries have reported that an OLYMPUS duodenoscope, specifically model TJFQ180V, has been marketed in the U.S. since 2010 without a 510(k) clearance by the U.S. Food and Drug Administration (FDA) for sale to hospitals and other licensed medical facilities.
Olympus Medical Systems Corporation (OMSC) made a decision, based upon FDA policy, that a modification to our previously FDA cleared duodenoscope did not require a new 510(k) application to FDA prior to marketing the modified duodenoscope in the U.S. in 2010.
As a medical device manufacturer, we remain committed to serving people worldwide by contributing in a meaningful and positive way to the healthcare environment, working in each country to adhere strictly to local regulations, follow sound business practices and conduct our business according to society's expectations.