FDA clears single-use gastroscope

The FDA has granted 510(k) regulatory clearance to Ambu's aScope, a single-use gastroscope, and aBox 2, a display unit, the company said Feb. 4. 

The aScope Gastro is Ambu's first sterile single-use gastroscope and includes imaging and design features. With its launch, Ambu enters the gastroscopy market, according to a news release from Ambu. 

Ambu also said it plans to introduce a single-use duodenoscope, a colonoscope and a cholangioscope.

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