510(k) Report

Devices descending from K190827

2 later devices reach Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192278Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath…Uvision360, Inc.20191—
+2K210512LUMINELLE DTx SystemUvision360, Inc.20210—