510(k) Report

Devices descending from K000180

37 later devices reach Transanal Endoscopic Microsurgery (Tem) Combination System and Instrument Set… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation201231Class I
+1K120898Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport Trucar 8850XX…Richard Wolf Medical Instruments Corp.20120—
+1K103253Sils PortCoviden (Formerly Registered AS US Surgical, A Div20114—
+2K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation202501
+2K161554Endoflator 40, Endoflator 50KARL STORZ Endoscopy-America, Inc.20171—
+2K143404SurgiQuest AirSeal iFS SystemSurgiquest, Inc.20152711
+2K110792Gelpoint PathApplied Medical Resources Corp.20113—
+3K221995Gas InsufflatorSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20230—
+3K172516SurgiQuest AIRSEAL iFS SystemConmed Corporation20188—
+3K171701GelPOINT Path Transanal Access PlatformApplied Medical Resources Corp.201701
+3K170784PneumoclearW.O.M. World of Medicine GmbH2017171
+3K133393Gelpoint Path Transanal Access PlatformApplied Medical Resources Corp.20141—
+4K242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.20250—
+4K201361PneumoclearW.O.M. World of Medicine GmbH202014—
+4K193520EVA 15 InsufflatorPalliare, Ltd.20205—
+4K191780AP50/30 Insufflator with Insuflow PortLexion Medical, LLC20190—
+4K190303AirSealConmed Corporation20191—
+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
+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—