510(k) Report

Devices descending from K083211

51 later devices reach Airseal Optical Trocar & Cannula System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112642Aquilex Fluid Control System H112W.O.M. World of Medicine AG201214—
+1K103692Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000Surgiquest, Inc.201135—
+2K180735Endomat SelectKarl Storz SE & CO. KG20182—
+2K180825Fluent Fluid Management SystemHologic, Inc.20182—
+2K173489GYN-Pump PH304W.O.M. World of Medicine GmbH201801
+2K172040Aquilex Fluid Control System AQL-100SW.O.M. World of Medicine GmbH201802
+2K143404SurgiQuest AirSeal iFS SystemSurgiquest, Inc.20152711
+2K132203Pneuview XE Veryclear Gas Evacuation CannulaLexion Medical, LLC20130—
+2K132169Surgiquest Airseal IfsSurgiquest, Inc.20130—
+2K123732Hysteroscopy Pump HM6W.O.M. World of Medicine AG20136—
+2K120640Insuflow Synergy PortLexion Medical, LLC20125—
+2K121336Modified Surgiquest Airseal Optical Trocar & Cannula System with Integrated Insufflator…Surgiquest, Inc.20124—
+3K240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System…Hologic, Inc.20240—
+3K233710Symphion Operative Hysteroscopy SystemMinerva Surgical, Inc.20240—
+3K201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG20201—
+3K190372Aveta SystemMeditrina, Inc.20194—
+3K172516SurgiQuest AIRSEAL iFS SystemConmed Corporation20188—
+3K170784PneumoclearW.O.M. World of Medicine GmbH2017171
+3K140263Insuflow Synergy Port, Insuflow Synergy XL PortLexion Medical, LLC20142—
+3K132204Insuflow Synergy XL PortLexion Medical, LLC20133—
+4K261706Endomat Select (UP220)Karl Storz SE & CO. KG20260—
+4K242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.20250—
+4K213171Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable…Meditrina, Inc.20221—
+4K201361PneumoclearW.O.M. World of Medicine GmbH202014—
+4K193520EVA 15 InsufflatorPalliare, Ltd.20205—
+4K192100Aveta Disposable HysteroscopeMeditrina, Inc.20190—
+4K191958Aveta SystemMeditrina, Inc.20190—
+4K191780AP50/30 Insufflator with Insuflow PortLexion Medical, LLC20190—
+4K190303AirSealConmed Corporation20191—
+4K170799AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC20171—
+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
+5K223813Aveta System 2.0Meditrina, Inc.20230—
+5K230474EVA5 InsufflatorPalliare, Ltd.20231—
+5K211104AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube SetConmed Corporation20210—
+5K202799EVA15Palliare, Ltd.20204—
+6K262152VS-370CF, VS-370CTVISION MEDICAL Co., Ltd.20260—
+6K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20262—
+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—
+6K222901EVA15 insufflatorPalliare, Ltd.20233—
+7K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+7K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+7K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+7K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—
+7K232902EVA15 insufflatorPalliare, Ltd.20240—