510(k) Report

Devices descending from K211227

2 later devices reach HTx Disposable Hysteroscope System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240401ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001…Origyn Medical Technology (Hangzhou) Co., Ltd.20240—
+1K231260HTx Disposable Hysteroscope SystemSuzhou AcuVu Medical Technology Co., Ltd.20240—