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  • Writer's pictureKBM

FDA Duodenoscope Update

The FDA's latest safety recommendation is to transition to innovative designs to enhance safety. This includes, moving away from fixed endcaps, use of disposables, quality checks, and better reprocessing procedures. Two duodenoscopes with disposable endcap design have been approved. They are:

1) Fujifilm Corporation, Duodenoscope model ED-580XT (cleared under K181745)

2) Pentax Medical, Duodenoscope model ED34-i10T (cleared under K163614 and K181522)

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