510(k) Report

Devices descending from K010740

16 later devices reach FG-36UX, Fiber Ultrasound Gastroscope through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041395EG-3630URPentax Precision Instrument Corp.20044—
+1K021278EG-3630UR, Ultrasound Video GastroscopePentax Precision Instrument Corp.200210—
+2K061068EG-3670URKPentax Medical Company200631
+2K023401EG-3830UT, Video Ultrasound GastroscopePentax Precision Instrument Corp.20039—
+3K090197EG-3870UTKPentax Medical Company200962
+3K090196EG-3670URKPentax Medical Company200921
+3K041397EG-3830UTPentax Precision Instrument Corp.200401
+3K031789EG-3830UT, Video Ultrasound GastroscopePentax Precision Instrument Corp.20030—
+4K130206Pentax EG-3670URK Ultrasound Video Gastroscope + HI Vision PreirusPentax of America, Inc.20131—
+4K130247Pentax EG-3870UTK Ultrasound Video Gastroscope + HI Vision PreirusPentax of America, Inc.201351
+5K231813Ultrasonic GastrovideoscopeSonoscape Medical Corp.20240—
+5K162447PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex…Pentax of America, Inc.20174—
+6K182004PENTAX Medical Endoscopic Ultrasound SystemPentax of America, Inc.201832
+7K200090PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI…Pentax of America, Inc.202022
+8K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+8K203166PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound…Pentax of America, Inc.20200—