510(k) Report

Devices descending from K950035

79 later devices reach Surgiflator 20 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K06336745L Core Insufflator, Model F114W.O.M. World of Medicine AG2007444
+1K955791Surgiflator-20 PimW.O.M. World of Medicine GmbH199633—
+2K230239AirSeal iFS System; AirSeal dV SolutionConmed Corporation20230—
+2K190303AirSealConmed Corporation20191—
+2K170799AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC20171—
+2K153513Insufflator 50L FM134W.O.M. World of Medicine GmbH201621—
+2K120151Nebulae INorthgate Technologies, Inc.2012222
+2K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation201132Class I
+2K103692Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000Surgiquest, Inc.201135—
+2K981859Surgiflator-20 EcuW.O.M. World of Medicine GmbH199831—
+2K973432Surgiflator-30W.O.M. World of Medicine GmbH19970—
+3K211104AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube SetConmed Corporation20210—
+3K191780AP50/30 Insufflator with Insuflow PortLexion Medical, LLC20190—
+3K170784PneumoclearW.O.M. World of Medicine GmbH2017171
+3K161554Endoflator 40, Endoflator 50KARL STORZ Endoscopy-America, Inc.20171—
+3K143404SurgiQuest AirSeal iFS SystemSurgiquest, Inc.20152711
+3K132203Pneuview XE Veryclear Gas Evacuation CannulaLexion Medical, LLC20130—
+3K132169Surgiquest Airseal IfsSurgiquest, Inc.20130—
+3K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation201231Class I
+3K120640Insuflow Synergy PortLexion Medical, LLC20125—
+3K121336Modified Surgiquest Airseal Optical Trocar & Cannula System with Integrated Insufflator…Surgiquest, Inc.20124—
+3K990443Arthro-Surgimat-2000 EcuW.O.M. World of Medicine GmbH199930—
+4K242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.20250—
+4K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation202501
+4K221995Gas InsufflatorSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20230—
+4K201361PneumoclearW.O.M. World of Medicine GmbH202014—
+4K172516SurgiQuest AIRSEAL iFS SystemConmed Corporation20188—
+4K140263Insuflow Synergy Port, Insuflow Synergy XL PortLexion Medical, LLC20142—
+4K132204Insuflow Synergy XL PortLexion Medical, LLC20133—
+4K033927Arthoscopy Pump A115W.O.M. World of Medicine AG20043—
+4K030402Arthroscopy Pump, Model A107W.O.M. World of Medicine AG200329—
+5K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KG20260—
+5K250388Endoflator +Karl Storz SE & CO. KG20251—
+5K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc.2024116
+5K193520EVA 15 InsufflatorPalliare, Ltd.20205—
+5K173311ARTHRO-Pump PA304W.O.M. World of Medicine GmbH20180—
+5K123441Stryker Crossflow Arthroscopy PumpStryker Endoscopy20135—
+5K063326Conmed Linvatec 24K Irrigation SystemConmed Linvatec20071—
+5K062380Flosimple Arthroscopy Pump A120W.O.M. World of Medicine AG2006151
+5K050580Smith & Nephew Intelijet Fluid Management SystemsSmith & Nephew Endoscopy, Inc.20052—
+6K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20262—
+6K250795Purevue™ FMSW.O.M. World of Medicine GmbH20250—
+6K251227da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+6K250442da Vinci Surgical System, IS5000Intuitive Surgical, Inc.20250—
+6K251213Da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+6K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20251—
+6K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+6K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242—
+6K230474EVA5 InsufflatorPalliare, Ltd.20231—
+6K202799EVA15Palliare, Ltd.20204—
+6K191259Stryker CrossFlow Integrated Arthroscopy PumpStryker Corp.20190—
+6K182882CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote ControlConmed Corporation20180—
+6K162770Relign SystemRelign Corporation20172—
+6K112642Aquilex Fluid Control System H112W.O.M. World of Medicine AG201214—
+6K051326Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc.200516
+7K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+7K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+7K262152VS-370CF, VS-370CTVISION MEDICAL Co., Ltd.20260—
+7K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+7K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—
+7K241008Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece…Relign Corporation, Subsidiary of Zimmer Biomet20240—
+7K233493Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece…Relign Corporation20231—
+7K222901EVA15 insufflatorPalliare, Ltd.20233—
+7K180735Endomat SelectKarl Storz SE & CO. KG20182—
+7K180825Fluent Fluid Management SystemHologic, Inc.20182—
+7K173489GYN-Pump PH304W.O.M. World of Medicine GmbH201801
+7K172040Aquilex Fluid Control System AQL-100SW.O.M. World of Medicine GmbH201802
+7K171794Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc.20170—
+7K123732Hysteroscopy Pump HM6W.O.M. World of Medicine AG20136—
+8K240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System…Hologic, Inc.20240—
+8K232902EVA15 insufflatorPalliare, Ltd.20240—
+8K233710Symphion Operative Hysteroscopy SystemMinerva Surgical, Inc.20240—
+8K201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG20201—
+8K190372Aveta SystemMeditrina, Inc.20194—
+9K261706Endomat Select (UP220)Karl Storz SE & CO. KG20260—
+9K213171Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable…Meditrina, Inc.20221—
+9K192100Aveta Disposable HysteroscopeMeditrina, Inc.20190—
+9K191958Aveta SystemMeditrina, Inc.20190—
+10K223813Aveta System 2.0Meditrina, Inc.20230—