510(k) Report

Devices descending from K163614

4 later devices reach PENTAX Medical ED34-i10T, Video Duodenoscope through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192245Pentax Medical Video Duodenoscope ED34-i10T2Pentax of America, Inc.201931
+2K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor…Pentax of America, Inc.20240—
+2K210710PENTAX Medical Video Duedenoscope ED34-i10T2Pentax of America, Inc.202101
+2K202365Pentax Medical Video Duodenoscope ED32-i10Pentax of America, Inc.20210—