510(k) Report

Devices descending from K153513

21 later devices reach Insufflator 50L FM134 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170799AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC20171—
+1K170784PneumoclearW.O.M. World of Medicine GmbH2017171
+1K161554Endoflator 40, Endoflator 50KARL STORZ Endoscopy-America, Inc.20171—
+2K242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.20250—
+2K221995Gas InsufflatorSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20230—
+2K201361PneumoclearW.O.M. World of Medicine GmbH202014—
+2K191780AP50/30 Insufflator with Insuflow PortLexion Medical, LLC20190—
+3K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KG20260—
+3K250388Endoflator +Karl Storz SE & CO. KG20251—
+3K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc.2024116
+4K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20262—
+4K251227da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+4K250442da Vinci Surgical System, IS5000Intuitive Surgical, Inc.20250—
+4K251213Da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+4K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20251—
+4K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+4K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242—
+5K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+5K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+5K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+5K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—