510(k) Report

Devices descending from K832006

11 later devices reach Pentax FD-34A Duodenofiberscope through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K963056ED-3410, Video DuodenoscopePentax Precision Instrument Corp.199692
+1K961568ED-344OTPentax Precision Instrument Corp.19960—
+2K092710Pentax ED-3490TK, Video DuodenoscopePentax Medical Company200982
+3K161222PENTAX MEDICAL ED-3490TK, Video DuodenoscopePentax Medical201861
+3K163614PENTAX Medical ED34-i10T, Video DuodenoscopePentax Medical20174—
+4K192245Pentax Medical Video Duodenoscope ED34-i10T2Pentax of America, Inc.201931
+4K181522PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video DuodenoscopePentax of America, Inc.20185—
+5K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor…Pentax of America, Inc.20240—
+5K210710PENTAX Medical Video Duedenoscope ED34-i10T2Pentax of America, Inc.202101
+5K202365Pentax Medical Video Duodenoscope ED32-i10Pentax of America, Inc.20210—
+5K192280PENTAX Medical ED-3490TK Video DuodenoscopePentax Medical20190—