FDA clears text

FDA Clears EndoFresh’s Disposable Gastrointestinal Endoscopy System

May 25, 2021

The FDA has granted EndoFresh 510(k) clearance for its disposable digestive endoscopy system, a device used to reduce the risk of contamination during gastrointestinal endoscopy procedures.

EndoFresh features a camera, a disposable upper gastrointestinal endoscope and a disposable colonoscope, and works with other peripheral devices to visualize and diagnose digestive disorders.

The device is designed to avoid the cross-contamination issues associated with the use of reprocessed endoscopes. The FDA recently issued warnings to healthcare providers about the risks of reprocessed urological devices, but gastrointestinal devices share some of the same risks.

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