510(k) Report

Devices descending from K071127

5 later devices reach Flexible Hysteroscope with Endosheath System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253905PrimeSight UltraView SystemCogentix Medical, Inc.20260—
+1K181909Luminelle DTx Hysteroscopy SystemUvision360, Inc.20183—
+2K190827Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath RigidUvision360, Inc.20192—
+3K192278Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath…Uvision360, Inc.20191—
+4K210512LUMINELLE DTx SystemUvision360, Inc.20210—