February 7, 2018 / 7:09 PM / 3 months ago

BRIEF-U.S. FDA Clears Design Changes To Pentax ED-3490TK Duodenoscope

Feb 7 (Reuters) - U.S. Food and Drug Administration:

* U.S. FDA SAYS, IN A NEW SAFETY COMMUNICATION, THAT IT IS ALERTING HEALTH CARE FACILITIES ABOUT A VOLUNTARY RECALL OF THE PENTAX ED-3490TK DUODENOSCOPE

* U.S. FDA SAYS RECALL OF PENTAX ED-3490TK DUODENOSCOPE IS TO MAKE CORRECTIONS TO ITS DESIGN THAT WILL HELP FACILITATE PROPER CLEANING AND DISINFECTION

* U.S. FDA SAYS IT HAS CLEARED A NEW 510(K) FOR THE ED-3490TK DUODENOSCOPE MODEL WITH A NEW ELEVATOR CHANNEL SEALING MECHANISM AT THE TIP OF THE SCOPE Source text: (bit.ly/2BdWKvg)

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