The Olympus duodenoscope model TJF-Q180V does not have FDA 510(k) clearance, but in its statement the FDA does not recommend cancelling ERCP procedures for patients in need. The device now has a pending 510(k) application, and the FDA does not plan to remove the device from the market for fear that such action could lead to a shortage of duodenoscopes.
The agency does not believe the lack of 510(k) clearance is associated with infections. Infections have been reported in cases involving all three major manufacturers of duodenoscopes.
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