510(k) Report

Devices descending from K080403

15 later devices reach XTJF Type Q160VF1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143153Evis Exera II Duodenovideoscope Olympus TJF Type Q180VOlympus Medical Systems Corp.2016143
+2K233886Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2Ambu A/S20241—
+2K201098Ambu Duodeno SystemAmbu Innovation GmbH20202—
+2K193182Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp.202054
+2K193202EXALT Model D Single-Use Duodenoscope, EXALT ControllerBoston Scientific Corporation201946
+3K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM…Fujifilm Corporation20260—
+3K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20223—
+3K202661Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp.202041
+4K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20251—
+4K250900EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20250—
+4K250701Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.20251—
+4K220587Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp.202214
+5K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20260—
+5K253646Single Use Distal Cover MAJ-2315 (MAJ-2315)Olympus Medical Systems Corp.20260—
+5K251867Evis Exera Iii Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.202501