510(k) Report

Devices descending from K052194

20 later devices reach Spyglass Direct Visualization Probe and Ocular through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142922SpyGlass DS Direct Visualization SystemBoston Scientific Corporation201591
+1K122042Cellvizio 100 Series and Cellvizio Systems with Confocal MiniprobesMauna Kea Technologies20128—
+1K090170Spyscope Access and Delivery CatheterBoston Scientific Corp200910—
+2K254153Single-use Video Scope; PB Digital ControllerMirco-Tech (Nanjing) Co., Ltd.20260—
+2K241444Biliary Pancreaticobiliary Scope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20250—
+2K221784Single-use Video Pancreaticobiliary Scope, PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20232—
+2K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation20187—
+2K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20176—
+2K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20157—
+3K252492Visualized Access and Delivery Catheter; PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20260—
+3K233752Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™…CenterPoint Systems, LLC20240—
+3K193416Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies20200—
+3K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20202—
+3K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies20194—
+3K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter…Boston Scientific Corporation20195—
+4K251338Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G…Scivita Medical Technology Co., Ltd.20260—
+4K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+4K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA20240—
+4K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies20210—
+4K200483SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerBoston Scientific Corporation20203—