510(k) Report

Devices descending from K193202

4 later devices reach EXALT Model D Single-Use Duodenoscope, EXALT Controller through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20223—
+2K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20251—
+2K250900EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20250—
+3K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20260—