Ambu earned FDA clearance for its aScope Gastro Large and Ambu aBox 2, the company said in an April 8 news release.
The aScope Gastro Large has a 4.2mm working channel and is designed for acute therapeutic procedures in the ICU. It also can be used for procedures outside the endoscopy unit such as surgical gastroscopies.
The gastroscope is the first single-use device of its kind with a 4.2mm working channel and the first endoscope made with bioplastics.