510(k) Report

Devices descending from K950166

21 later devices reach Olympus KD-6G1-9Q Wire Guided Papillotomu Knife through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122505Single Use Preloaded Sphincterotome VOlympus Medical Systems Corp.20137—
+1K011149Disposable Bending Cannula PR-233QThe Olympus Optical Co.200112—
+2K150142Single Use Balloon Dilator V (with Knife)Olympus Medical Systems Corp.20151—
+2K141991Single Use Preloaded Sphincterotome V (Distal Wireguided); Single Use SPOlympus Medical Systems Copr.201543
+2K090170Spyscope Access and Delivery CatheterBoston Scientific Corp200910—
+2K051504Spyscope Access and Delivery CatheterBoston Scientific Corp200511—
+3K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use…Olympus Medical Systems Corp.2025016
+3K192339TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordWilson-Cook Medical, Inc.20201—
+3K193039Single Use Balloon Dilator V (with knife)Olympus Medical Systems Corp.20190—
+3K160241Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215Olympus Medical Systems Corp.201601
+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—
+4K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc.202501
+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—