510(k) Report

Devices descending from K904993

265 later devices reach Laparoscopic Electrosurgical Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K231224da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.202313—
+5K223095Senhance Surgical SystemAsensus Surgical, Inc.20231Class I
+5K212614Ultrasonic Scalpel SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20221—
+5K2200238mm Monopolar Curved ScissorsIntuitive Surgical, Inc.202211
+5K211104AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube SetConmed Corporation20210—
+5K202571da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2020141
+5K192717da Vinci SP Surgical SystemIntuitive Surgical, Inc.202041
+5K192803da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical20200—
+5K191780AP50/30 Insufflator with Insuflow PortLexion Medical, LLC20190—
+5K180351EndoWrist Mercury Bipolar GrasperIntuitive Surgical, Inc.201802
+5K180575THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.20180—
+5K172610THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.201843
+5K171426da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degreeIntuitive Surgical, Inc.20171—
+5K171294da Vinci X Surgical SystemIntuitive Surgical, Inc.20173110
+5K170908PK AIMGyrus Acmi, Inc.20170—
+5K170784PneumoclearW.O.M. World of Medicine GmbH2017171
+5K161554Endoflator 40, Endoflator 50KARL STORZ Endoscopy-America, Inc.20171—
+5K160554Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20166—
+5K161271da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201613—
+5K152892da Vinci Xi Surgical SystemIntuitive Surgical201612—
+5K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+5K151794da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201612—
+5K150284IS4000 da Vinci EndoWrist InstrumentsIntuitive Surgical, Inc.201508
+5K150837IS4000 Small Clip Applier, IS4000 Long Bipolar ForcepsIntuitive Surgical, Inc.201503
+5K143404SurgiQuest AirSeal iFS SystemSurgiquest, Inc.20152711
+5K14268312 mm Endoscopes and AccessoriesIntuitive Surgical, Inc.20141—
+5K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc.2014872
+5K131962DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.201422—
+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—
+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—
+6K2514908 mm Assist Cannula; 12 mm Assist CannulaIntuitive Surgical, Inc.20250—
+6K242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.20250—
+6K242427da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.20250—
+6K2426108mm Monopolar Curved Scissors (470179)Iconocare Health20250—
+6K243582da Vinci SP Advanced Access Port Kit (432701)Intuitive Surgical, Inc.20250—
+6K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation202501
+6K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+6K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242—
+6K233036Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd.20240—
+6K230033Da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202312—
+6K221995Gas InsufflatorSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20230—
+6K210918da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20216—
+6K202968Da Vinci SP Surgical SystemIntuitive Surgical, Inc.202031
+6K201361PneumoclearW.O.M. World of Medicine GmbH202014—
+6K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+6K200841Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11Ethicon Endo-Surgery, LLC20204—
+6K191529da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical202012—
+6K191736da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30Intuitive Surgical20190—
+6K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2018219
+6K172516SurgiQuest AIRSEAL iFS SystemConmed Corporation20188—
+6K163548ENSEAL X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20170—
+6K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.2016701
+6K140263Insuflow Synergy Port, Insuflow Synergy XL PortLexion Medical, LLC20142—
+6K132204Insuflow Synergy XL PortLexion Medical, LLC20133—
+7K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC20260—
+7K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+7K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KG20260—
+7K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+7K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+7K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—
+7K250388Endoflator +Karl Storz SE & CO. KG20251—
+7K243067The ETHICON™ Total Energy SystemEthicon Endo-Surgery, LLC (A Johnson and Johnson Company)20250—
+7K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…Stryker Sustainability Solutions20240—
+7K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…Stryker Sustainability Solutions20241—
+7K231798da Vinci SP Surgical SystemIntuitive Surgical, Inc.202311—
+7K213710da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20222—
+7K212101da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20212—
+7K211316da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202111
+7K202582Arthrex SynergyID Endoscopic Imaging SystemArthrex, Inc.20215—
+7K211595da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202101
+7K193520EVA 15 InsufflatorPalliare, Ltd.20205—
+7K192292L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight CableStryker20191—
+7K182606PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker)201844—
+7K1821601688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head…Stryker2018331
+7K161792PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.201668—
+8K2603184K NIR/ICG Imaging SystemZhejiang Healnoc Technology Co., Ltd.20260—
+8K250786SP Endoscope, 0° (430600)Intuitive Surgical, Inc.20251—
+8K243591OPTOVISION Endoscopic Light Source UnitOptosurgical, LLC20250—
+8K240502da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20249—
+8K233840Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)Zhuhai Dipu Medical Technology Co., Ltd.20240—
+8K2338923D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)Zhuhai Dipu Medical Technology Co., Ltd.20240—
+8K232773da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20240—
+8K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker20235—
+8K230474EVA5 InsufflatorPalliare, Ltd.20231—
+8K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+8K221591Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)…Schoelly Fiberoptic GmbH20231—
+8K221861FloNavi Endoscopic Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20232—
+8K221252Scivita 4KINSIGHT ICG Imaging SystemScivita Medical Technology Co., Ltd.20230—
+8K222827da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20220—
+8K212808Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation20220—
+8K212747Da Vinci SP Surgical SystemIntuitive Surgical, Inc.20210—
+8K202925KARL STORZ ICG Imaging SystemKarl Storz Endoscopy_America, Inc.20207—