510(k) Report

Devices descending from K081137

211 later devices reach Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K200542Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video…Olympus Medical Systems Corp.20200—
+4K191529da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical202012—
+4K192877Senhance Surgical SystemTransenterix, Inc.20197—
+4K192292L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight CableStryker20191—
+4K191736da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30Intuitive Surgical20190—
+4K182606PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker)201844—
+4K1821601688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head…Stryker2018331
+4K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc.201871
+4K173866Stryker AIM Light Source and SafeLight cableStryker201834—
+4K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201732—
+4K161792PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.201668—
+4K151243STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]Stryker Endoscopy201534—
+5K254180PerfusiX-ImagingLIMIS Development B.V.20260—
+5K253994TroKit Laparoscope Lens WiperTroCare, LLC20260—
+5K2603184K NIR/ICG Imaging SystemZhejiang Healnoc Technology Co., Ltd.20260—
+5K260089TL-10 Laparoscopic Scope CleanerScopix, Ltd.20260—
+5K250786SP Endoscope, 0° (430600)Intuitive Surgical, Inc.20251—
+5K243591OPTOVISION Endoscopic Light Source UnitOptosurgical, LLC20250—
+5K233840Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)Zhuhai Dipu Medical Technology Co., Ltd.20240—
+5K2338923D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)Zhuhai Dipu Medical Technology Co., Ltd.20240—
+5K231798da Vinci SP Surgical SystemIntuitive Surgical, Inc.202311—
+5K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker20235—
+5K231344ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.20230—
+5K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+5K221591Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)…Schoelly Fiberoptic GmbH20231—
+5K221861FloNavi Endoscopic Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20232—
+5K221252Scivita 4KINSIGHT ICG Imaging SystemScivita Medical Technology Co., Ltd.20230—
+5K222827da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20220—
+5K212808Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation20220—
+5K211316da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202111
+5K211595da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202101
+5K202925KARL STORZ ICG Imaging SystemKarl Storz Endoscopy_America, Inc.20207—
+5K202592Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality…Stryker202026—
+5K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20208—
+5K200049Senhance Surgical SystemTransenterix, Inc.20206—
+5K2003101688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with…Stryker20200—
+5K191851VS3-IRMedtronic20196—
+5K191046L10 LED Light Source with AIM, L11 LED Light Source with AIMStryker20192—
+5K183107Intuitive Surgical Vessel Sealer ExtendIntuitive Surgical, Inc.20186—
+5K180146KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc.201830—
+5K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201731—
+6K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+6K260108L12 LED Light Source with AIMStryker Endoscopy20260—
+6K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…Olympus Medical Systems Corp.20250—
+6K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+6K252350da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20250—
+6K250674Vessel Sealer Curved (480522)Intuitive Surgical, Inc.20250—
+6K233391cCeLL - In vivoVPIX Medical, Inc.20240—
+6K241530Stellar Imaging SystemGuangdong Optomedic Technologies, Inc.20241—
+6K240502da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20249—
+6K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+6K232773da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20240—
+6K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+6K2333271788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+6K230407FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20230—
+6K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker)20234—
+6K223020VS3-Iridium System (VS3-IR)Visionsense, Ltd.20220—
+6K210265VS3 Iridium SytemVisionsense, Ltd.20215—
+6K212695KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America20215—
+6K212747Da Vinci SP Surgical SystemIntuitive Surgical, Inc.20210—
+6K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…Stryker202119—
+6K2100881688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM…Stryker202125—
+6K202166Senhance Surgical SystemTransenterix, Inc.20215—
+6K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker)20205—
+6K201399HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid…Karl Storz-Endoscopy-America, Inc.20208—
+6K191280E-100 Electrosurgical Generator, SynchroSealIntuitive Surgical, Inc.201942
+7K262547KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KG20260—
+7K253602Precision S 4K SinuscopeStryker Endoscopy20260—
+7K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation20260—
+7K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+7K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…Stryker Endoscopy20260—
+7K2526973D LaparoscopeGuangdong Optomedic Technologies, Inc.20250—
+7K243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbH20250—
+7K243008Arthrex NanoScope SystemArthrex, Inc.20254—
+7K242318da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20247—
+7K241814da Vinci SP Instruments (SP1098)Intuitive Surgical, Inc.20240—
+7K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+7K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG20232—
+7K232857KARL STORZ ICG Imaging SystemKarl Storz SE & CO. KG20230—
+7K222240Explorer Air® IISurgvision GmbH20231—
+7K223039da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20223—
+7K2221301688 4K Camera System with Advanced Imaging ModalityStryker20220—
+7K221217SPY LaparoscopeStryker20221—
+7K214046780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight CableStryker202214—
+7K2208951688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K…Stryker20220—
+7K220477Cellvizio 100 series system with confocal MiniprobesMauna Kea Technologies20221—
+7K2125111688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K…Stryker20210—
+7K212054Senhance Surgical SystemAsensus Surgical, Inc.20213—
+7K211325Senhance Surgical SystemAsensus Surgical, Inc.20210—
+8K251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.20260—
+8K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG20260—
+8K252640VereSee Optical Veres Needle and Endoscopic CameraFreyja Healthcare, LLC20251—
+8K251324da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+8K252010SPY LaparoscopeStryker Endoscopy20250—
+8K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+8K243714da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20255—
+8K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH20240—
+8K231212da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20232—
+8K230754L12 LED Light Source with AIMStryker20236—
+8K2306051788 4K Camera System with Advanced Imaging ModalityStryker20236—