510(k) Report

Devices descending from K142629

6 later devices reach EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210162Endoscope Model EI-740D/SFujifilm Corporation20215—
+2K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S20260—
+2K253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc.20260—
+2K221551FUJIFILM Endoscope Model EI-740D/SFujifilm Corporaton20232—
+3K260824Gastrointestinal Videoscope Olympus GIF-2T1500Olympus Medical Systems Corporation20260—
+3K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas Corporation20240—