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Medical Devices / Submissions and Approvals

FDA Clears First Duodenoscope With Disposable Distal Cap

Oct. 3, 2017
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Following deadly superbug outbreaks linked to contaminated duodenoscopes, the FDA has cleared the first duodenoscope with a disposable distal cap to improve access for cleaning.

Flexible duodenoscopes provide access to upper gastrointestinal tracts to treat bile duct disorders. However, they must be thoroughly cleaned and disinfected to prevent contaminated tissue or fluid from being trapped in the adhesive, the agency said.

CDRH acting director William Maisel called the clearance of Pentax of America’s ED34-i10T a major step toward lowering the risk of future infections associated with the devices.

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