510(k) Report

Devices descending from K143153

14 later devices reach Evis Exera II Duodenovideoscope Olympus TJF Type Q180V through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233886Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2Ambu A/S20241—
+1K201098Ambu Duodeno SystemAmbu Innovation GmbH20202—
+1K193182Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp.202054
+1K193202EXALT Model D Single-Use Duodenoscope, EXALT ControllerBoston Scientific Corporation201946
+2K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM…Fujifilm Corporation20260—
+2K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20223—
+2K202661Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp.202041
+3K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20251—
+3K250900EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20250—
+3K250701Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.20251—
+3K220587Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp.202214
+4K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20260—
+4K253646Single Use Distal Cover MAJ-2315 (MAJ-2315)Olympus Medical Systems Corp.20260—
+4K251867Evis Exera Iii Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.202501