Ambu Gets FDA Clearance for Single-Use Duodenoscope

The FDA has granted Ambu 510(k) clearance for its aScope Duodeno, a duodenoscope with a disposable endoscope.

The device includes a single-use endoscope and a reusable processor unit, both of which are covered by the clearance.

In August 2019, the FDA expressed concerns about duodenoscopes, citing continually high levels of contamination and difficulties in cleaning them for reuse, and urged users to switch to products with disposable components.