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FDA Clears Custom Ultrasonics to Resume Manufacturing Endoscope Reprocessor

June 30, 2017

The FDA cleared devicemaker Custom Ultrasonics to resume manufacture of its System 83 endoscope washer-disinfector.

The agency had previously required the company to perform validation testing for the device’s water filtration system and its inline disc filter. The filters underwent testing by independent laboratories with no change in design, and the agency then accepted the performance data, the company said.

The FDA has reinstated the use of the components in flexible endoscopes that are not duodenoscopes.  The company is currently working with the FDA to validate the system for duodenoscopes, and it strongly recommends against reprocessing those until further notice. — Zack Budryk

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