Ambu Gets 510(k) Clearance for Its Single-Use Gastroscope and Display Unit

Denmark-based Ambu has received the FDA’s 510(k) clearance for its single-use aScope Gastro gastroscope in combination with its reusable Ambu aBox 2 display unit.

The single-use scope avoids the problems associated with reusable endoscope systems that require reprocessing for sterility.   

Thanks to its sterility, the single-use aScope Gastro can reduce the cross-contamination risks of reusable devices, especially for vulnerable patients, the company said.