510(k) Report

Devices descending from K191415

6 later devices reach Pathfinder Endoscope Overtube through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc.20260—
+1K230752Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)FUJIFILM Healthcare Americas Corporation20231—
+1K211301Pathfinder Endoscope OvertubeNeptune Medical, Inc.20213—
+2K243091Over-tube (TR-1108A)Fujifilm Corporation20240—
+2K240853Pathfinder® CR SystemNeptune Medical, Inc.20240—
+2K230801Pathfinder Endoscope Overtube with Balloon DeviceNeptune Medical, Inc.20230—