510(k) Report

Devices descending from K181522

5 later devices reach PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192245Pentax Medical Video Duodenoscope ED34-i10T2Pentax of America, Inc.201931
+1K192280PENTAX Medical ED-3490TK Video DuodenoscopePentax Medical20190—
+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—