510(k) Report

Devices descending from K021278

10 later devices reach EG-3630UR, Ultrasound Video Gastroscope through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023401EG-3830UT, Video Ultrasound GastroscopePentax Precision Instrument Corp.20039—
+2K090197EG-3870UTKPentax Medical Company200962
+2K041397EG-3830UTPentax Precision Instrument Corp.200401
+2K031789EG-3830UT, Video Ultrasound GastroscopePentax Precision Instrument Corp.20030—
+3K130247Pentax EG-3870UTK Ultrasound Video Gastroscope + HI Vision PreirusPentax of America, Inc.201351
+4K162447PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex…Pentax of America, Inc.20174—
+5K182004PENTAX Medical Endoscopic Ultrasound SystemPentax of America, Inc.201832
+6K200090PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI…Pentax of America, Inc.202022
+7K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+7K203166PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound…Pentax of America, Inc.20200—