510(k) Report

Devices descending from K904797

116 later devices reach Surgitek Graduated Cystoscope (Model GC-16) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K151275MAKO DeviceNvision Medical20152—
+8K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9…Guangzhou Red Pine Medical Instrument Co., Ltd.20260—
+8K252793ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope…Jiangsu Jiyuan Medical Technology Co., Ltd.20250—
+8K242699Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope…Opcom Medical, Inc.20250—
+8K243857Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)Shanghai AnQing Medical Instrument Co., Ltd.20251—
+8K232003Endoscopic Video Image Processor, Single-Use Video HysteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.20243—
+8K222737Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)Shanghai AnQing Medical Instrument Co., Ltd.20220—
+8K190639Endosee SystemCooperSurgical, Inc.201931
+8K160510MAKO 7Nvision Medical Corporation20161—
+9K252806Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US…Shanghai AnQing Medical Instrument Co., Ltd.20250—
+9K240978SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G…MacroLux Medical Technology Co., Ltd.20241—
+9K241987Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)Guangzhou Red Pine Medical Instrument Co., Ltd.20240—
+9K200038Endosee SystemCooperSurgical, Inc.20201—
+9K182975MAKO 7Boston Scientific Corporation20190—
+10K254294Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A…Zhejiang Geyi Medical Instrument Co., Ltd.20260—
+10K254251InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument Co., Ltd.20260—