510(k) Report

Devices descending from K031846

46 later devices reach Cardiovations Optical Bipolar Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K06072340 L High Flow Insufflator F113W.O.M. World of Medicine AG200645—
+2K06336745L Core Insufflator, Model F114W.O.M. World of Medicine AG2007444
+3K230239AirSeal iFS System; AirSeal dV SolutionConmed Corporation20230—
+3K190303AirSealConmed Corporation20191—
+3K170799AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC20171—
+3K153513Insufflator 50L FM134W.O.M. World of Medicine GmbH201621—
+3K120151Nebulae INorthgate Technologies, Inc.2012222
+3K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation201132Class I
+3K103692Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000Surgiquest, Inc.201135—
+4K211104AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube SetConmed Corporation20210—
+4K191780AP50/30 Insufflator with Insuflow PortLexion Medical, LLC20190—
+4K170784PneumoclearW.O.M. World of Medicine GmbH2017171
+4K161554Endoflator 40, Endoflator 50KARL STORZ Endoscopy-America, Inc.20171—
+4K143404SurgiQuest AirSeal iFS SystemSurgiquest, Inc.20152711
+4K132203Pneuview XE Veryclear Gas Evacuation CannulaLexion Medical, LLC20130—
+4K132169Surgiquest Airseal IfsSurgiquest, Inc.20130—
+4K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation201231Class I
+4K120640Insuflow Synergy PortLexion Medical, LLC20125—
+4K121336Modified Surgiquest Airseal Optical Trocar & Cannula System with Integrated Insufflator…Surgiquest, Inc.20124—
+5K242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.20250—
+5K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation202501
+5K221995Gas InsufflatorSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20230—
+5K201361PneumoclearW.O.M. World of Medicine GmbH202014—
+5K172516SurgiQuest AIRSEAL iFS SystemConmed Corporation20188—
+5K140263Insuflow Synergy Port, Insuflow Synergy XL PortLexion Medical, LLC20142—
+5K132204Insuflow Synergy XL PortLexion Medical, LLC20133—
+6K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KG20260—
+6K250388Endoflator +Karl Storz SE & CO. KG20251—
+6K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc.2024116
+6K193520EVA 15 InsufflatorPalliare, Ltd.20205—
+7K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20262—
+7K251227da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+7K250442da Vinci Surgical System, IS5000Intuitive Surgical, Inc.20250—
+7K251213Da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+7K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20251—
+7K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+7K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242—
+7K230474EVA5 InsufflatorPalliare, Ltd.20231—
+7K202799EVA15Palliare, Ltd.20204—
+8K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+8K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+8K262152VS-370CF, VS-370CTVISION MEDICAL Co., Ltd.20260—
+8K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+8K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—
+8K222901EVA15 insufflatorPalliare, Ltd.20233—
+9K232902EVA15 insufflatorPalliare, Ltd.20240—