510(k) Report

Devices descending from K001533

52 later devices reach Surgiflator-40 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K03083740 L High Flow Insufflator F108W.O.M. World of Medicine AG200451—
+2K231342Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.20230—
+2K222812InsufflatorScivita Medical Technology Co., Ltd.20232—
+2K090652Alpha Duo Lap InsufflatorHippokratec GmbH20090—
+2K06072340 L High Flow Insufflator F113W.O.M. World of Medicine AG200645—
+3K252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology, Ltd.20260—
+3K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.20260—
+3K06336745L Core Insufflator, Model F114W.O.M. World of Medicine AG2007444
+4K230239AirSeal iFS System; AirSeal dV SolutionConmed Corporation20230—
+4K190303AirSealConmed Corporation20191—
+4K170799AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC20171—
+4K153513Insufflator 50L FM134W.O.M. World of Medicine GmbH201621—
+4K120151Nebulae INorthgate Technologies, Inc.2012222
+4K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation201132Class I
+4K103692Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000Surgiquest, Inc.201135—
+5K211104AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube SetConmed Corporation20210—
+5K191780AP50/30 Insufflator with Insuflow PortLexion Medical, LLC20190—
+5K170784PneumoclearW.O.M. World of Medicine GmbH2017171
+5K161554Endoflator 40, Endoflator 50KARL STORZ Endoscopy-America, Inc.20171—
+5K143404SurgiQuest AirSeal iFS SystemSurgiquest, Inc.20152711
+5K132203Pneuview XE Veryclear Gas Evacuation CannulaLexion Medical, LLC20130—
+5K132169Surgiquest Airseal IfsSurgiquest, Inc.20130—
+5K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation201231Class I
+5K120640Insuflow Synergy PortLexion Medical, LLC20125—
+5K121336Modified Surgiquest Airseal Optical Trocar & Cannula System with Integrated Insufflator…Surgiquest, Inc.20124—
+6K242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.20250—
+6K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation202501
+6K221995Gas InsufflatorSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20230—
+6K201361PneumoclearW.O.M. World of Medicine GmbH202014—
+6K172516SurgiQuest AIRSEAL iFS SystemConmed Corporation20188—
+6K140263Insuflow Synergy Port, Insuflow Synergy XL PortLexion Medical, LLC20142—
+6K132204Insuflow Synergy XL PortLexion Medical, LLC20133—
+7K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KG20260—
+7K250388Endoflator +Karl Storz SE & CO. KG20251—
+7K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc.2024116
+7K193520EVA 15 InsufflatorPalliare, Ltd.20205—
+8K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20262—
+8K251227da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+8K250442da Vinci Surgical System, IS5000Intuitive Surgical, Inc.20250—
+8K251213Da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+8K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20251—
+8K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+8K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242—
+8K230474EVA5 InsufflatorPalliare, Ltd.20231—
+8K202799EVA15Palliare, Ltd.20204—
+9K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+9K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+9K262152VS-370CF, VS-370CTVISION MEDICAL Co., Ltd.20260—
+9K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+9K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—
+9K222901EVA15 insufflatorPalliare, Ltd.20233—
+10K232902EVA15 insufflatorPalliare, Ltd.20240—