510(k) Report

Devices descending from K981928

5 later devices reach Galileo Disposable Endoscopes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192300EnlightenVue Microendoscopy SystemEnlightenvue, Inc.20200—
+1K991377Omnisonics Flexible Fiber Optic Endoscope and CouplerOmnisonics Medical Technologies19992—
+1K982630Medworks Visualization Insemination CatheterMedworks Corp.19990—
+2K080780Anchorage Scope, Model 000003Epitek, Inc.20080—
+2K993445Omnisonic Endoscopic DeflectorOmnisonics Medical Technologies19990—