510(k) Report

Devices descending from K904799

16 later devices reach CHF-B20 Choledochoscope through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082576XCHF-T160 VideoscopeOlympus Medical Systems Corporation20081—
+1K051886Olympus Choledochoscope, Model XCHF-BP160FOlympus Medical Systems Corporation200513—
+2K123704Automated Endoscope Leak TesterOlympus Medical Systems Corp.20131—
+2K113120CHF-Y0005Olympus Medical Systems Corp.20120—
+2K090170Spyscope Access and Delivery CatheterBoston Scientific Corp200910—
+3K212201PENTAX Medical Auto Leakage Tester SHA-P6Pentax of America, Inc.20210—
+3K142922SpyGlass DS Direct Visualization SystemBoston Scientific Corporation201591
+4K254153Single-use Video Scope; PB Digital ControllerMirco-Tech (Nanjing) Co., Ltd.20260—
+4K241444Biliary Pancreaticobiliary Scope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20250—
+4K221784Single-use Video Pancreaticobiliary Scope, PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20232—
+4K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation20187—
+5K252492Visualized Access and Delivery Catheter; PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20260—
+5K233752Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™…CenterPoint Systems, LLC20240—
+5K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter…Boston Scientific Corporation20195—
+6K251338Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G…Scivita Medical Technology Co., Ltd.20260—
+6K200483SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerBoston Scientific Corporation20203—