510(k) Report

Devices descending from K983326

34 later devices reach Omniflator 7640 Model 7-640-00 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K014166Uhi-3 High Flow Insufflation UnitOlympus Optical Co., Ltd.200233Class I
+2K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation201132Class I
+3K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation201231Class I
+4K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation202501
+4K161554Endoflator 40, Endoflator 50KARL STORZ Endoscopy-America, Inc.20171—
+4K143404SurgiQuest AirSeal iFS SystemSurgiquest, Inc.20152711
+5K221995Gas InsufflatorSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20230—
+5K172516SurgiQuest AIRSEAL iFS SystemConmed Corporation20188—
+5K170784PneumoclearW.O.M. World of Medicine GmbH2017171
+6K242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.20250—
+6K201361PneumoclearW.O.M. World of Medicine GmbH202014—
+6K193520EVA 15 InsufflatorPalliare, Ltd.20205—
+6K191780AP50/30 Insufflator with Insuflow PortLexion Medical, LLC20190—
+6K190303AirSealConmed Corporation20191—
+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
+7K230474EVA5 InsufflatorPalliare, Ltd.20231—
+7K211104AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube SetConmed Corporation20210—
+7K202799EVA15Palliare, Ltd.20204—
+8K262152VS-370CF, VS-370CTVISION MEDICAL Co., Ltd.20260—
+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—
+8K222901EVA15 insufflatorPalliare, Ltd.20233—
+9K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+9K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+9K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+9K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—
+9K232902EVA15 insufflatorPalliare, Ltd.20240—