510(k) Report

Devices descending from K040237

258 later devices reach Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K230033Da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202312—
+4K210918da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20216—
+4K202968Da Vinci SP Surgical SystemIntuitive Surgical, Inc.202031
+4K191529da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical202012—
+4K190081RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber…STERIS Corporation20194—
+4K191736da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30Intuitive Surgical20190—
+4K181517Senhance Surgical SystemTransenterix, Inc.201810—
+4K180163TransEnterix Senhance Surgical SystemTransenterix, Inc.201811—
+4K170879IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30…Intuitive Surgical, Inc.20170—
+4K171388EndoWrist Stapler 45 System and Stapler 45 ReloadsIntuitive Surgical, Inc.20171—
+4K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site…Intuitive Surgical, Inc.20178—
+4K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.2016701
+4K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+4K150705FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic…Minimally Invasive Devices, Inc.20153—
+4K124031DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc.2013103—
+4K130726DA Vinci Single-Site Permanent Cautery HookIntuitive Surgical, Inc.201327
+4K123548The Artas SystemRestoration Robotics, Inc.201314
+4K123154Artas System From Restoration RoboticsRestoration Robotics, Inc.20130—
+4K120215Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper, Single-Site Fundus…Intuitive Surgical, Inc.2012423
+5K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+5K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+5K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+5K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—
+5K241796TroCare TroKit Laparoscope Lens Wiper (CP000626)TroCare, LLC20242—
+5K231798da Vinci SP Surgical SystemIntuitive Surgical, Inc.202311—
+5K213943SmartSurgN Visualization SystemSmartsurgn Incorporated20221—
+5K213710da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20222—
+5K212101da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20212—
+5K211316da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202111
+5K202582Arthrex SynergyID Endoscopic Imaging SystemArthrex, Inc.20215—
+5K211595da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202101
+5K200577RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber…STERIS Corporation20203—
+5K192292L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight CableStryker20191—
+5K191482Senhance Surgical SystemTransenterix, Inc.20198—
+5K183098Senhance Surgical SystemTransenterix, Inc.20180—
+5K182606PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker)201844—
+5K1821601688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head…Stryker2018331
+5K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc.201871
+5K173358ARTAS SystemRestoration Robotics, Inc.20180—
+5K161792PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.201668—
+5K152583KARL STORZ Endoscopic ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201636—
+5K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+5K142310Stryker Infrared Fluorescence (IRF) Imaging SystemStryker Endoscopy201476—
+5K133203Single-Site PortIntuitive Surgical, Inc.20140—
+6K253994TroKit Laparoscope Lens WiperTroCare, LLC20260—
+6K2603184K NIR/ICG Imaging SystemZhejiang Healnoc Technology Co., Ltd.20260—
+6K242163SmartSurgN Visualization SystemSmartsurgN, Inc.20260—
+6K260089TL-10 Laparoscopic Scope CleanerScopix, Ltd.20260—
+6K250786SP Endoscope, 0° (430600)Intuitive Surgical, Inc.20251—
+6K243591OPTOVISION Endoscopic Light Source UnitOptosurgical, LLC20250—
+6K240502da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20249—
+6K233840Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)Zhuhai Dipu Medical Technology Co., Ltd.20240—
+6K2338923D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)Zhuhai Dipu Medical Technology Co., Ltd.20240—
+6K232773da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20240—
+6K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker20235—
+6K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+6K221591Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)…Schoelly Fiberoptic GmbH20231—
+6K221861FloNavi Endoscopic Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20232—
+6K221252Scivita 4KINSIGHT ICG Imaging SystemScivita Medical Technology Co., Ltd.20230—
+6K222827da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20220—
+6K212808Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation20220—
+6K212747Da Vinci SP Surgical SystemIntuitive Surgical, Inc.20210—
+6K203550ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.20212—
+6K202925KARL STORZ ICG Imaging SystemKarl Storz Endoscopy_America, Inc.20207—
+6K203199RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single…STERIS Corporation20202—
+6K202592Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality…Stryker202026—
+6K200542Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video…Olympus Medical Systems Corp.20200—
+6K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20208—
+6K2003101688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with…Stryker20200—
+6K191851VS3-IRMedtronic20196—
+6K192877Senhance Surgical SystemTransenterix, Inc.20197—
+6K191046L10 LED Light Source with AIM, L11 LED Light Source with AIMStryker20192—
+6K183107Intuitive Surgical Vessel Sealer ExtendIntuitive Surgical, Inc.20186—
+6K173866Stryker AIM Light Source and SafeLight cableStryker201834—
+6K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201732—
+6K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+6K151243STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]Stryker Endoscopy201534—
+7K254180PerfusiX-ImagingLIMIS Development B.V.20260—
+7K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+7K260108L12 LED Light Source with AIMStryker Endoscopy20260—
+7K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…Olympus Medical Systems Corp.20250—
+7K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+7K252350da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20250—
+7K250674Vessel Sealer Curved (480522)Intuitive Surgical, Inc.20250—
+7K242318da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20247—
+7K241814da Vinci SP Instruments (SP1098)Intuitive Surgical, Inc.20240—
+7K241530Stellar Imaging SystemGuangdong Optomedic Technologies, Inc.20241—
+7K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+7K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+7K2333271788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+7K231344ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.20230—
+7K230407FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20230—
+7K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker)20234—
+7K223020VS3-Iridium System (VS3-IR)Visionsense, Ltd.20220—
+7K222543AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris20221—
+7K210265VS3 Iridium SytemVisionsense, Ltd.20215—
+7K212695KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America20215—
+7K2100881688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM…Stryker202125—
+7K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker)20205—
+7K200049Senhance Surgical SystemTransenterix, Inc.20206—