510(k) Report

Devices descending from K180096

3 later devices reach GDT-1000 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211227HTx Disposable Hysteroscope SystemAcuvu, Inc.20212—
+2K240401ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001…Origyn Medical Technology (Hangzhou) Co., Ltd.20240—
+2K231260HTx Disposable Hysteroscope SystemSuzhou AcuVu Medical Technology Co., Ltd.20240—