510(k) Report

Devices descending from K063367

44 later devices reach 45L Core Insufflator, Model F114 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230239AirSeal iFS System; AirSeal dV SolutionConmed Corporation20230—
+1K190303AirSealConmed Corporation20191—
+1K170799AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC20171—
+1K153513Insufflator 50L FM134W.O.M. World of Medicine GmbH201621—
+1K120151Nebulae INorthgate Technologies, Inc.2012222
+1K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation201132Class I
+1K103692Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000Surgiquest, Inc.201135—
+2K211104AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube SetConmed Corporation20210—
+2K191780AP50/30 Insufflator with Insuflow PortLexion Medical, LLC20190—
+2K170784PneumoclearW.O.M. World of Medicine GmbH2017171
+2K161554Endoflator 40, Endoflator 50KARL STORZ Endoscopy-America, Inc.20171—
+2K143404SurgiQuest AirSeal iFS SystemSurgiquest, Inc.20152711
+2K132203Pneuview XE Veryclear Gas Evacuation CannulaLexion Medical, LLC20130—
+2K132169Surgiquest Airseal IfsSurgiquest, Inc.20130—
+2K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation201231Class I
+2K120640Insuflow Synergy PortLexion Medical, LLC20125—
+2K121336Modified Surgiquest Airseal Optical Trocar & Cannula System with Integrated Insufflator…Surgiquest, Inc.20124—
+3K242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.20250—
+3K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation202501
+3K221995Gas InsufflatorSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20230—
+3K201361PneumoclearW.O.M. World of Medicine GmbH202014—
+3K172516SurgiQuest AIRSEAL iFS SystemConmed Corporation20188—
+3K140263Insuflow Synergy Port, Insuflow Synergy XL PortLexion Medical, LLC20142—
+3K132204Insuflow Synergy XL PortLexion Medical, LLC20133—
+4K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KG20260—
+4K250388Endoflator +Karl Storz SE & CO. KG20251—
+4K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc.2024116
+4K193520EVA 15 InsufflatorPalliare, Ltd.20205—
+5K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20262—
+5K251227da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+5K250442da Vinci Surgical System, IS5000Intuitive Surgical, Inc.20250—
+5K251213Da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+5K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20251—
+5K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+5K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242—
+5K230474EVA5 InsufflatorPalliare, Ltd.20231—
+5K202799EVA15Palliare, Ltd.20204—
+6K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+6K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+6K262152VS-370CF, VS-370CTVISION MEDICAL Co., Ltd.20260—
+6K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+6K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—
+6K222901EVA15 insufflatorPalliare, Ltd.20233—
+7K232902EVA15 insufflatorPalliare, Ltd.20240—